Personforce Jobs

Regulatory Affairs Specialist III/IV

Sat, 01 Sep 2007 12:00:00 EST

Regulatory Affairs Specialist III/IV

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Regulatory Affairs Specialist III/IV to become a member of our dynamic team.

Responsibilities:

Performs the coordination and preparation of document packages for regulatory submissions (US and international).
Compiles all materials required in submissions, license renewal and annual registrations.
Under limited supervision, reviews critical documents to assure completeness and prepares responses to routine in-country representative or regulatory agency requests.
Ensures that the content, organization and overall quality of all regulatory documentation are adequate and sufficient to meet local and/or regional regulatory requirements, commitments and agreements.
Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters.
Represent regulatory affairs on project teams.
Develops and recommends strategies for earliest possible approvals of device license applications.
Assists the team in development of tracking documents and follow to assure submissions are completed on time.
Generates departmental procedures.
Ensures documents are apostilled, certified, legalized or notarized as required.
Assess new and/or modified standards, regulations and/or laws and determine applicability to the organization and/or product i.e. IEC 60601. In addition, this position shall lead the project teams to ensure implementation of new or modified standards or regs.

Qualifications:

Qualified applicants must have a Bachelor\'s Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
5-8+ years Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components)
Strong knowledge or experience in Japan Shonin Process
Proven track record in obtaining worldwide regulatory approvals.
A second language is preferred. (i.e. Japanese, Chinese, French, French, Japanese)
Able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel, Access and PowerPoint)
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors
Strong critical thinking, communication, and problem solving skills.
Competence in applying scientific principles and logical thought processes in preparing regulatory documentation.
Detail-oriented with ability to accomplish objectives with minimal supervision.
Effective working within teams, influential, and able to negotiate to reach optimal decision.
Experience with Standards (ISO, IEC, EN) and HIPPA are desirable.

When responding to this position please refer to job code: STF.211.012

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-44412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

EMAIL to Accuray Incorporated EMAIL TO A FRIEND

Supplier Quality Engineer

Sat, 01 Sep 2007 12:00:00 EST

Supplier Quality Engineer

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Supplier Quality Engineer to become a member of our dynamic team.

Responsibilities:

Provide supplier qualifications, material issue resolution, drive supplier corrective actions, component/BOM validation, supplier audits, and maintain approved supplier list.
Participate and provide feedback to New Product Development Teams to ensure new product features meet quality, reliability, manufacturability and cost requirements; support the development, qualification, verification and manufacture of medical devices, including process improvement efforts that meet or exceed internal and external regulatory requirements.
Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving supplier quality issues.
Initiate and review ECOs. Interface with manufacturing engineering groups and suppliers to troubleshoot quality/reliability issues and implement effective solutions.
Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non –compliance and ensure timely/effective corrections and /or corrective preventative actions are implemented and verified.
Develop and support an effective incoming material quality and dock-to-stock program.
Participate in Risk Analysis as appropriate.
Interface with suppliers on the use of Quality Engineering methodologies, tools, regulatory requirements, etc and assist in solving day-to-day quality issues.
Develop and revise supplier policies and procedures in line with the Quality System.
Assist in Development of V & V Protocols, Technical Investigation Plans, Engineering Reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements; provide innovative solutions to minimize costs.

Qualifications:

Bachelor Degree in Engineering, Quality or Other.
3 years experience in Quality, medical device regulations and or a manufacturing environment.
Expertise in Statistical Methodologies and Analysis.
Understand in failure modes/FA tools for mechanical and electrical components and systems.
Competency in ISO-13485/ISO 9001 and 21 CFR 820 Quality System Requirements
Proven commitment to continuous improvement.
Excellent analytical and problem-solving skills combined with a strong technical presence.
Experience in the manufacture of high voltage electrical systems, high power microwave devices and linear accelerators is a plus.

When responding to this position please refer to job code: STF.220.014

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Technical Writer

Sat, 01 Sep 2007 12:00:00 EST

Technical Writer

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Technical Writer to become a member of our dynamic team.

RESPONSIBILITIES:

Position goals:

Contribute to improvements in consistency and quality of existing user manuals/documentation.
Act as tech pub team engineering change order process expert, including configuration management of user documentation.
Implement structural, template, and content changes to existing user documentation.
Contribute to the identification and implementation of innovative document creation and distribution strategies.

Specific tasks or functions:

Serve as the Technical Publications point of contact for document services.
Consolidate and revise existing customer product documentation.
Contribute to consistent implementation of terminology and style in manuals and coordinate with other departments to manage consistency in the user interface, release notes, training material, and user manuals.
As appropriate, work as an individual contributor or coordinate and implement the review and input of others. Coordinate with external resources as necessary.
As appropriate, write new “technical” documents and provide assistance to other departments needing technical writing support.
Produce and release product support materials and process changes to technical documents.

QUALIFICATIONS:

BS/BA in English, Communications, Business, Engineering, or related field (or comparable experience)
Minimum 2-4 years primary experience in writing technical user documentation in a medical device environment for a range of users.
Experience working with multiple subject matter experts and data sources to develop and verify content.
Attention to detail and able to meet aggressive deadlines with high quality.
Excellent writing, editing, and proofreading skills.
Advanced skills: A database management system; Microsoft Office including Word, Excel, Paint, and Power Point. Also: Adobe FrameMaker, Acrobat, Photoshop, and Illustrator, various HTML programs.
Commitment to excellence and ongoing improvement. Be a problem solver with strong oral and written communication skills, able to work independently and in a team environment.

When responding to this position please refer to job code: STF.211.011

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-44412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

EMAIL to Accuray Incorporated EMAIL TO A FRIEND

Account Manager, Northwest

Sat, 01 Sep 2007 12:00:00 EST

Account Manager, Northwest

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for an Account Manager, Northwest to become a member of our dynamic team.

Responsibilities:

Serves as the liaison between the company and customer during the implementation of their CyberKnife program and post installation to ensure clinical and business performance success.
Develops growth strategies with customer\'s hospital and medical leadership to drive utilization of the CyberKnife by adopting clinical applications of importance to the company.
Regular customer site visits, with intensive interaction with hospital executives, physicians and other clinical staff.
Ensures customer satisfaction with the CyberKnife acquisition and Accuray by managing the details of overall project timelines and company deliverables.
Extensive internal interaction with employees in clinical development, training, product marketing, sales, customer support and other members of cross-functional teams focused on the delivery of products and services to the customer.
Works very closely with Placement/Shared Ownership partnership sites toward mutual clinical and business goals to build awareness and support of the overall strategic benefits of the partnership.
Provides for financial analyses, long-term forecasting and analysis associated with regional Placement/Shared Ownership partners.
Works with hospital executives, marketing representatives, and physicians to analyze the local market data to identify trends/opportunities, develop strategic-direction from market information and create compelling marketing plans for local implementation.
Educate hospital financial leadership (CFO, VP Finance, Dept Directors, Accounts Receivable) on proper usage of billing codes associated with CyberKnife procedures
Coordination of the technical & clinical training for surgeons, radiation oncologists, physicist, nurses and therapists
90% out of state regional travel is required.

Qualifications:

Strong medical/clinical background and advanced degree preferred (R.N., M.B.A., M.H.A., R.T.T.).
Must be comfortable in hospital settings and working with hospital personnel at all levels (executives, physicians, physicists and support staff)
Strong project management skills required
Excellent demonstrated verbal and written communication skills
Demonstrated ability to multitask and follow-through
Strong marketing and educational background
Working knowledge of hospital and physician reimbursement
Excellent public speaking and leadership skills
Work experience as hospital manager, medical device marketing or sales, especially neurosurgery or oncology a plus
Radiation therapy background desirable
Extensive regional travel required

When responding to this position please refer to job code: STF.550.009

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Manager, Clinical Programs (Lung)

Sat, 01 Sep 2007 12:00:00 EST

Manager, Clinical Programs (Lung)

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Manager, Clinical Programs (Lung) to become a member of our dynamic team.

Responsibilities:

Global responsibility to drive programs focusing on specific treatment applications targeting complex patient groups, or subset groups for CyberKnife Robotic Radiosurgery.
Work closely with customers to identify existing and new clinical treatment opportunities and techniques to support clinical treatment applications\' growth strategy.
Where necessary, recruit surgical and radiation specialists, especially within academic institutions to focus on driving existing treatment techniques and developing new clinical treatment applications.
Drive a decision on competing new applications within Accuray in large part by providing an in-depth clinical perspective.
Work closely with Clinicians to develop research hypothesis and clinical studies to investigate key clinical questions.
Be instrumental in identifying and encouraging clinical publications and conference presentations.
Own an assigned clinical application area by creating a compelling array of "products" to develop, sustain, or enhance leadership position within the clinical specialty.
Work with product development to optimize CyberKnife features for a specific clinical segment.
Work with internal Accuray personnel to create sales tools to communicate clinical strengths.
Develop the "Go-To-Market" strategy for clinical application of new product introductions, in collaboration with the product marketing team.
Participate actively in on-site and in-house customer visits, product demonstrations and training activities with emphasis on clinical techniques.
Define market opportunities and develop tactical plans to drive increased market acceptance within clinical specialty area. Provide clinical, technical and technology insights to Engineering and Marketing.
Recruit, manage and work with clinical advisory sub-specialty group.
Create and support customer outreach activities by utilizing third party CME and editorial programs, peer-to-peer conferences, customer education programs, company sponsored symposia and third party endorsements.
Manage partnerships with Radiosurgical hospital staff for clinical applications projects and studies.
Liaise with Marketing and Engineering to ensure successful implementation and integration of Accuray solutions.
Produce, monitor, and report clinical studies\' status against project work plan and budget.

Qualifications:

Minimum 5 years relevant experience developing and implementing clinical and technical solutions in the healthcare and medical device arena.
Management experience preferred but not required.
M.D. degree preferred.
Must have a clinical background, experience in pioneering new procedures, and excellent communication skills working directly with medical specialists such as surgeons, radiation and medical oncologists and physicists, and must be capable of leading cross-functional project teams including hospital staff, Marketing and Engineering.
Demonstrated ability to lead diverse project teams, manage deliverables to milestones.
Ability to strategize, analyze, prioritize, and facilitate resolution of all project related issues.
Strong management skills, interpersonal skills, oral and written communication skills, ability to work well with a wide range of people and the executive management team.
Travel is required.

When responding to this position please refer to job code: STF.521.013

Human Resources E-Mail: jchau@accuray.com

Human Resources Phone: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Marketing Analyst

Sat, 01 Sep 2007 12:00:00 EST

Marketing Analyst

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Marketing Analyst to become a member of our dynamic team.

RESPONSIBILITIES:

Marketing Database Administration (Existing Customers)

Design, develop and manage new market intelligence database
Port existing site/service elements from Microsoft Excel into new database architecture
Incorporate patient capture data elements from Microsoft Excel into defined database architecture
Manage ongoing data input and auditing, ensuring accurate and timely data availability
Define, compile, and distribute regular dashboard reports to key stakeholders
Provide executive ad-hoc reporting as needed
Develop standardized and custom report writing mechanisms; train select users to independently extract data
Develop methods to automate data input and regular reporting
Prepare database for eventual migration to CRM system

Market Research & Survey Management (Prospective Customers)

Develop, manage, and execute "prospect/market research database" efforts including data gathering of detailed prospective customer information and related market research. Formats may include electronic kiosk surveys or paper surveys. Forums may include exhibitions, user meetings, symposia, special events, etc.
Prior to defined event, collaboratively develop most appropriate and prioritized survey data elements
Develop and maintain database consisting of new and previously gathered surveys
After each event, follow-up with Sales, Marketing, and Executive staff with executive summaries of data gathered
Query and pull targeted contact lists from the database as needed

QUALIFICATIONS:

Bachelor\'s degree in Business or Science or 2 years of relevant marketing data analysis and data base administration required
Experience in Microsoft Access database creation; proficient with related database maintenance and report writing 1 data query
Strong analytical skills a must
Experience in medical devices a plus
Ability to think outside the box and creatively analyze, interpret, and present data

When responding to this position please refer to job code: STF.520.012

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Patient Relations Manager

Sat, 01 Sep 2007 12:00:00 EST

Patient Relations Manager

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Patient Relations Manager to become a member of our dynamic team.

Responsibilities:

Support and manage the area of patient awareness, support, and education.
Educate the public regarding the benefits of radiosurgery and CyberKnife.
Create, facilitate, and moderate a medium for patients to interact with caregivers, other patients, prospective patients, and others.
Focus on patient specific content and deploy in appropriate media such as web, patient brochures, etc.
Coordinate, manage, facilitate and support the patient focused activities of Accuray.
Serve as patient and family advocate within Accuray.
Support and build relationships with existing cancer related patient support organizations.
Attend meetings and conferences focused on patient education and awareness.
Work with Marketing Communications to create synergies between DTC efforts and patient outreach. Increase visibility of CyberKnife throughout all media opportunities: Patient portraits, stories, spokespeople, patient magazines, radio stations, websites, etc.
Respond to emails and phone calls from prospective patients and family and direct them to the appropriate place.
Support CK Society efforts as they relate to patient advocacy and outreach activities.
Serve as primary liaison between patients and Accuray.
Stay knowledgeable regarding regulatory requirements and company policies such as HIPPA.

Qualifications:

MD required. (RN or Physician Assistant will also be considered.)
Must have prior medical and/or patient focused experience – CyberKnife experience is a plus
Must be able to think strategically and execute tactically while working alone and with a team
Must have excellent interpersonal skills with huge amounts of empathy and listening skills
Experience managing patient registry/database is a plus
Must have excellent writing, organization and project management skills
Non-profit experience is a plus
Must be located at Accuray Sunnyvale Headquarters
Public relations and general media experience is a plus
Ability to travel is a must

When responding to this position please refer to job code: STF.502.001

Human Resources E-Mail: jchau@accuray.com

Human Resources Phone: 408 789 4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Health Payment and Policy Manager

Sat, 01 Sep 2007 12:00:00 EST

Health Payment and Policy Manager

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Health Payment and Policy Manager to become a member of our dynamic team.

Responsibilities:

Work with HP&P team developing & executing the strategic & tactical reimbursement program for U.S. initiatives
Refine coverage policies of public and private payers to include new applications and new technologies for both hospitals and physicians
Track & trend coverage policies, payment policies and collection analyses of U.S. payers for both hospitals and physicians
Interact with public & private payers for both hospitals and physicians
Research & document coverage & payment policies for all regions & major private payers, nationally, regionally & locally
Understand how payment is obtained & revised in all regions with all payers
Develop specific strategies to assist providers in overcoming limited coverage with private payers; customize the message for key payers regarding clinical outcomes, economic outcomes and impact for the payer given its subscriber base; work with providers to implement solutions
Determine alternative mechanisms for funding procedures where there is no coverage before formal reimbursement is achieved
Direct formal application for coding & coverage with public & private payers where necessary
Assist development of health technology assessments & theoretical economic assessment models to support coverage applications
Assist development of comparative cost & payment models vs. other treatment modalities
Assist development of medical necessity justifications for physician payment support
Develop influential health economic analyses, including budget impact analyses, cost effectiveness and cost utility studies vs. other std treatments and other modalities
Provide in-house and field-based support and assistance to hospitals, physicians and their support staff in the reimbursement process (TBD)
Work with Clin Dev to ensure that the required economic outcomes information meeting quality thresholds is in development and becomes available for use
Monitor & report reimbursement trends internally

Qualifications:

§ 40-50% travel required; some international travel possible

§ Bachelor’s degree required, master’s degree preferred

§ 8-10+ years of total business experience with 3-5 years experience specifically within healthcare economics and reimbursement

§ Must have knowledge of reimbursement, government/commercial payers systems

§ Fundamental knowledge of worldwide public & private healthcare systems, especially relative to new technologies/procedures/services

§ Experience with vendor selection & contract negotiation, ability to manage relationships & results of contractors and consultants

§ Experience with high end capital medical equipment

§ Proficient with office tools, such as MS Word, MS Excel, MS PowerPoint, data analyses, etc

§ Demonstrated ability to work within team environment and fast-growing company

§ Excellent presentation skills

§ Natural ability to establish rapport & build relationships

§ Ability to successfully navigate political environments

§ Proven experience in developing and executing medical (equipment, device, pharma) reimbursement strategies desirable

§ Knowledge of health technology assessment protocols, practices & methods desirable

§ Knowledge of cost analysis, cost-effectiveness evaluations, clinical and economic outcomes including the interpretation and presentation of clinical and economic data desirable

§ Experience initiating new applications for coverage & coding for new technologies desirable

When responding to this position please refer to job code: STF.525.004

Human Resources E-Mail: jchau@accuray.com

Human Resources Pone: 408 789 4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Graphics Specialist

Sat, 01 Sep 2007 12:00:00 EST

Graphics Specialist

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Graphics Specialist to become a member of our dynamic team.

Responsibilities:

Graphics Design:
- Produce graphic and visual materials for promotions, newsletters, brochures, marketing collateral, packaging, presentations, and information and instructional material through a variety of media outlets.
- Prepare master storyboards, layouts, artwork, and final production mechanicals of stated projects as well as traditional print deliverables.
- Define the project scope and cost estimates and assist in controlling the quality, cost and timeliness of projects and services - ability to balance multiple projects as necessary.
- Creation/management of PowerPoint graphics, templates, presentations and animations for corporate external and internal presentations.
- Develop and maintain vendor relationships, and coordinate of production for external products and services.
Web Content Management:
- Manage the design and maintenance of the Accuray corporate website.
- Creation, implementation, and management of site content, modifications, design, and navigation strategy.
- Manage tasks and workflow related to web content.
- Provide support and leadership to site users and authors.
- Define, develop and adhere to site style guide and content rules that provide a consistent voice, tone, and style of online content.
- Write, edit, and produce content, as necessary.
- Conduct regular content inventory to determine availability, editing needs, and development as necessary.
- Develop internal/external contacts/content providers to ensure access to key information and subject matter experts.

Qualifications:

Extensive experience in key applications: InDesign, Illustrator, Photoshop, Acrobat, Microsoft Office (PowerPoint, Word, Excel).
Strong concept and design skills, strong typography skills, an excellent eye for layout.
Pre-press/Press knowledge - print/color/stock knowledge, knows how to proofread, review proofs, attend press checks.
Demonstrated Web Design and Development skills (HTML, JavaScript, Dreamweaver, FrontPage and CGI scripts), advanced animation and video.
Strong familiarity and practical knowledge of relevant tools, including Microsoft SharePoint, Server and Microsoft Office applications.
Proven track record and demonstrated success as a web content project manager and editor.
Copywriting and editorial skills.
Solid project management skills with a proven ability to meet specifications and deadlines.
Excellent analytical skills and ability to propose, develop, review new concepts.
Working knowledge of website Information Architecture and website usability best practices.
B.A./B.S. degree or equivalent experience in Graphic design or Computer related discipline preferred.
Minimum 3 - 5 years graphic design experience preferred.
Minimum 3 - 5 years desktop publishing experience preferred.
Basic HTML knowledge preferred.
Extremely creative, out of the box thinker preferred.
Deadline driven! Ability to prioritize and work under tight deadlines preferred.
Able to work on multiple projects in a fast paced work environment preferred.
Able to work quickly, but not compromise quality of work preferred.
Strong organizational skills to manage multiple demands and objectives preferred.
Able to produce professional results and make sound decisions on projects with minimum supervision preferred.
High level of integrity; ability to preserve the confidentiality of sensitive information preferred.
Flexible work schedule to meet project demands preferred.
Able to work effectively in a team environment preferred.
Excellent written and oral communication skills preferred.

When responding to this position please refer to job code:STF.523.008

Human Resources E-Mail: jchau@accuray.com Resources

Human Resources Phone: 408 716 4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Product Manager

Sat, 01 Sep 2007 12:00:00 EST

Product Manager

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Product Manager to become a member of our dynamic team.

Responsibilities:

Direct the worldwide development of market requirements for treatment delivery products and features for the CyberKnife system
Work closely with Radiation Oncologists, Medical Physicists, Dosimetrists and Surgeons in order to define the product and market needs and translate those requirements into Marketing Requirements Documents for product development
Develop and recommend strategies for technical solutions based on the analysis of the customer’s business needs, objectives, and existing system infrastructure.
Strongly influence the design, development and testing of products by working effectively with the Clinical Development, Research and Engineering groups ensure customer and market needs are being met
Interface with the cross-functional New Product Introduction teams to drive strategic, marketing and customer product objectives during the product rollout process
Establish worldwide price positioning, pricing strategies, margin analysis and forecasts for treatment delivery products
Develop and oversee product positioning and differentiation in the marketplace maintaining a competitive edge in the treatment delivery market
Communicate, coordinate and monitor all product related market penetration, competitive strategies and product issues with both domestic and international sales as well as multiple international distributors.
Direct product launch activities and manage product strategy at trade shows while being responsible for product presentations and demos.
Responsible for driving the generation of sell sheets, brochures, animations and other collateral through the Marketing Communications department to educate, promote and sell the treatment delivery aspects of the CyberKnife system
Create, update and delivery sales training curricula and materials for our direct sales force and account managers as well as for distributors
Responsible for driving product performance to meet market needs
Maintain strategic focus to drive the growth of the business while also maximizing enhancements to the existing product line
Create, update and execute annual marketing plans and champion new business plans as required
Participate in sales and VIP presentations in addition to supporting ongoing team activities.
Assist Clinical Development group by finding new market opportunities for treatment with the CyberKnife and helping define and develop customer user interfaces

Qualifications:

BS degree (MA, MBA, MS or equivalent desired) and minimum 5-7 years of experience in the medical device field; classic product marketing required (bonus if in radiation therapy/oncology).
Must have excellent communication skills and be able to develop positive business relationships with all functional areas within Accuray as well as the medical community and Accuray customers.
Must have strong analytical skills.
Able to establish goals and meet department and corporate objectives.

When responding to this position please refer to job code: STF.520.007

Human Resources E-Mail: jfernandes@accuray.com

Human Resources Phone: 408 789 4296

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Regulatory Affairs Specialist III/IV

Thu, 01 Jan 1970 04:59:59 EST

Regulatory Affairs Specialist III/IV

Responsibilities:

Performs the coordination and preparation of document packages for regulatory submissions (US and international).
Compiles all materials required in submissions, license renewal and annual registrations.
Under limited supervision, reviews critical documents to assure completeness and prepares responses to routine in-country representative or regulatory agency requests.
Ensures that the content, organization and overall quality of all regulatory documentation are adequate and sufficient to meet local and/or regional regulatory requirements, commitments and agreements.
Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters.
Represent regulatory affairs on project teams.
Develops and recommends strategies for earliest possible approvals of device license applications.
Assists the team in development of tracking documents and follow to assure submissions are completed on time.
Generates departmental procedures.
Ensures documents are apostilled, certified, legalized or notarized as required.
Assess new and/or modified standards, regulations and/or laws and determine applicability to the organization and/or product i.e. IEC 60601. In addition, this position shall lead the project teams to ensure implementation of new or modified standards or regs.

Qualifications:

Qualified applicants must have a Bachelor\'s Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
5-8+ years Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components)
Strong knowledge or experience in Japan Shonin Process
Proven track record in obtaining worldwide regulatory approvals.
A second language is preferred. (i.e. Japanese, Chinese, French, French, Japanese)
Able to communicate effectively (verbal and written) and be proficient in Microsoft Office (Word, Excel, Access and PowerPoint)
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors
Strong critical thinking, communication, and problem solving skills.
Competence in applying scientific principles and logical thought processes in preparing regulatory documentation.
Detail-oriented with ability to accomplish objectives with minimal supervision.
Effective working within teams, influential, and able to negotiate to reach optimal decision.
Experience with Standards (ISO, IEC, EN) and HIPPA are desirable.

When responding to this position please refer to job code: STF.211.012

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-44412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

EMAIL to Accuray Incorporated EMAIL TO A FRIEND

Supplier Quality Engineer

Thu, 01 Jan 1970 04:59:59 EST

Supplier Quality Engineer

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Supplier Quality Engineer to become a member of our dynamic team.

Responsibilities:

Provide supplier qualifications, material issue resolution, drive supplier corrective actions, component/BOM validation, supplier audits, and maintain approved supplier list.
Participate and provide feedback to New Product Development Teams to ensure new product features meet quality, reliability, manufacturability and cost requirements; support the development, qualification, verification and manufacture of medical devices, including process improvement efforts that meet or exceed internal and external regulatory requirements.
Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving supplier quality issues.
Initiate and review ECOs. Interface with manufacturing engineering groups and suppliers to troubleshoot quality/reliability issues and implement effective solutions.
Perform Supplier Quality Audits and, as appropriate, Internal Quality System Audits; identify root cause of non –compliance and ensure timely/effective corrections and /or corrective preventative actions are implemented and verified.
Develop and support an effective incoming material quality and dock-to-stock program.
Participate in Risk Analysis as appropriate.
Interface with suppliers on the use of Quality Engineering methodologies, tools, regulatory requirements, etc and assist in solving day-to-day quality issues.
Develop and revise supplier policies and procedures in line with the Quality System.
Assist in Development of V & V Protocols, Technical Investigation Plans, Engineering Reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements; provide innovative solutions to minimize costs.

Qualifications:

Bachelor Degree in Engineering, Quality or Other.
3 years experience in Quality, medical device regulations and or a manufacturing environment.
Expertise in Statistical Methodologies and Analysis.
Understand in failure modes/FA tools for mechanical and electrical components and systems.
Competency in ISO-13485/ISO 9001 and 21 CFR 820 Quality System Requirements
Proven commitment to continuous improvement.
Excellent analytical and problem-solving skills combined with a strong technical presence.
Experience in the manufacture of high voltage electrical systems, high power microwave devices and linear accelerators is a plus.

When responding to this position please refer to job code: STF.220.014

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Technical Writer

Thu, 01 Jan 1970 04:59:59 EST

Technical Writer

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Technical Writer to become a member of our dynamic team.

RESPONSIBILITIES:

Position goals:

Contribute to improvements in consistency and quality of existing user manuals/documentation.
Act as tech pub team engineering change order process expert, including configuration management of user documentation.
Implement structural, template, and content changes to existing user documentation.
Contribute to the identification and implementation of innovative document creation and distribution strategies.

Specific tasks or functions:

Serve as the Technical Publications point of contact for document services.
Consolidate and revise existing customer product documentation.
Contribute to consistent implementation of terminology and style in manuals and coordinate with other departments to manage consistency in the user interface, release notes, training material, and user manuals.
As appropriate, work as an individual contributor or coordinate and implement the review and input of others. Coordinate with external resources as necessary.
As appropriate, write new “technical” documents and provide assistance to other departments needing technical writing support.
Produce and release product support materials and process changes to technical documents.

QUALIFICATIONS:

BS/BA in English, Communications, Business, Engineering, or related field (or comparable experience)
Minimum 2-4 years primary experience in writing technical user documentation in a medical device environment for a range of users.
Experience working with multiple subject matter experts and data sources to develop and verify content.
Attention to detail and able to meet aggressive deadlines with high quality.
Excellent writing, editing, and proofreading skills.
Advanced skills: A database management system; Microsoft Office including Word, Excel, Paint, and Power Point. Also: Adobe FrameMaker, Acrobat, Photoshop, and Illustrator, various HTML programs.
Commitment to excellence and ongoing improvement. Be a problem solver with strong oral and written communication skills, able to work independently and in a team environment.

When responding to this position please refer to job code: STF.211.011

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-44412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

EMAIL to Accuray Incorporated EMAIL TO A FRIEND

Account Manager, Northwest

Thu, 01 Jan 1970 04:59:59 EST

Account Manager, Northwest

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for an Account Manager, Northwest to become a member of our dynamic team.

Responsibilities:

Serves as the liaison between the company and customer during the implementation of their CyberKnife program and post installation to ensure clinical and business performance success.
Develops growth strategies with customer\'s hospital and medical leadership to drive utilization of the CyberKnife by adopting clinical applications of importance to the company.
Regular customer site visits, with intensive interaction with hospital executives, physicians and other clinical staff.
Ensures customer satisfaction with the CyberKnife acquisition and Accuray by managing the details of overall project timelines and company deliverables.
Extensive internal interaction with employees in clinical development, training, product marketing, sales, customer support and other members of cross-functional teams focused on the delivery of products and services to the customer.
Works very closely with Placement/Shared Ownership partnership sites toward mutual clinical and business goals to build awareness and support of the overall strategic benefits of the partnership.
Provides for financial analyses, long-term forecasting and analysis associated with regional Placement/Shared Ownership partners.
Works with hospital executives, marketing representatives, and physicians to analyze the local market data to identify trends/opportunities, develop strategic-direction from market information and create compelling marketing plans for local implementation.
Educate hospital financial leadership (CFO, VP Finance, Dept Directors, Accounts Receivable) on proper usage of billing codes associated with CyberKnife procedures
Coordination of the technical & clinical training for surgeons, radiation oncologists, physicist, nurses and therapists
90% out of state regional travel is required.

Qualifications:

Strong medical/clinical background and advanced degree preferred (R.N., M.B.A., M.H.A., R.T.T.).
Must be comfortable in hospital settings and working with hospital personnel at all levels (executives, physicians, physicists and support staff)
Strong project management skills required
Excellent demonstrated verbal and written communication skills
Demonstrated ability to multitask and follow-through
Strong marketing and educational background
Working knowledge of hospital and physician reimbursement
Excellent public speaking and leadership skills
Work experience as hospital manager, medical device marketing or sales, especially neurosurgery or oncology a plus
Radiation therapy background desirable
Extensive regional travel required

When responding to this position please refer to job code: STF.550.009

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Manager, Clinical Programs (Lung)

Thu, 01 Jan 1970 04:59:59 EST

Manager, Clinical Programs (Lung)

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Manager, Clinical Programs (Lung) to become a member of our dynamic team.

Responsibilities:

Global responsibility to drive programs focusing on specific treatment applications targeting complex patient groups, or subset groups for CyberKnife Robotic Radiosurgery.
Work closely with customers to identify existing and new clinical treatment opportunities and techniques to support clinical treatment applications\' growth strategy.
Where necessary, recruit surgical and radiation specialists, especially within academic institutions to focus on driving existing treatment techniques and developing new clinical treatment applications.
Drive a decision on competing new applications within Accuray in large part by providing an in-depth clinical perspective.
Work closely with Clinicians to develop research hypothesis and clinical studies to investigate key clinical questions.
Be instrumental in identifying and encouraging clinical publications and conference presentations.
Own an assigned clinical application area by creating a compelling array of "products" to develop, sustain, or enhance leadership position within the clinical specialty.
Work with product development to optimize CyberKnife features for a specific clinical segment.
Work with internal Accuray personnel to create sales tools to communicate clinical strengths.
Develop the "Go-To-Market" strategy for clinical application of new product introductions, in collaboration with the product marketing team.
Participate actively in on-site and in-house customer visits, product demonstrations and training activities with emphasis on clinical techniques.
Define market opportunities and develop tactical plans to drive increased market acceptance within clinical specialty area. Provide clinical, technical and technology insights to Engineering and Marketing.
Recruit, manage and work with clinical advisory sub-specialty group.
Create and support customer outreach activities by utilizing third party CME and editorial programs, peer-to-peer conferences, customer education programs, company sponsored symposia and third party endorsements.
Manage partnerships with Radiosurgical hospital staff for clinical applications projects and studies.
Liaise with Marketing and Engineering to ensure successful implementation and integration of Accuray solutions.
Produce, monitor, and report clinical studies\' status against project work plan and budget.

Qualifications:

Minimum 5 years relevant experience developing and implementing clinical and technical solutions in the healthcare and medical device arena.
Management experience preferred but not required.
M.D. degree preferred.
Must have a clinical background, experience in pioneering new procedures, and excellent communication skills working directly with medical specialists such as surgeons, radiation and medical oncologists and physicists, and must be capable of leading cross-functional project teams including hospital staff, Marketing and Engineering.
Demonstrated ability to lead diverse project teams, manage deliverables to milestones.
Ability to strategize, analyze, prioritize, and facilitate resolution of all project related issues.
Strong management skills, interpersonal skills, oral and written communication skills, ability to work well with a wide range of people and the executive management team.
Travel is required.

When responding to this position please refer to job code: STF.521.013

Human Resources E-Mail: jchau@accuray.com

Human Resources Phone: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Marketing Analyst

Thu, 01 Jan 1970 04:59:59 EST

Marketing Analyst

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Marketing Analyst to become a member of our dynamic team.

RESPONSIBILITIES:

Marketing Database Administration (Existing Customers)

Design, develop and manage new market intelligence database
Port existing site/service elements from Microsoft Excel into new database architecture
Incorporate patient capture data elements from Microsoft Excel into defined database architecture
Manage ongoing data input and auditing, ensuring accurate and timely data availability
Define, compile, and distribute regular dashboard reports to key stakeholders
Provide executive ad-hoc reporting as needed
Develop standardized and custom report writing mechanisms; train select users to independently extract data
Develop methods to automate data input and regular reporting
Prepare database for eventual migration to CRM system

Market Research & Survey Management (Prospective Customers)

Develop, manage, and execute "prospect/market research database" efforts including data gathering of detailed prospective customer information and related market research. Formats may include electronic kiosk surveys or paper surveys. Forums may include exhibitions, user meetings, symposia, special events, etc.
Prior to defined event, collaboratively develop most appropriate and prioritized survey data elements
Develop and maintain database consisting of new and previously gathered surveys
After each event, follow-up with Sales, Marketing, and Executive staff with executive summaries of data gathered
Query and pull targeted contact lists from the database as needed

QUALIFICATIONS:

Bachelor\'s degree in Business or Science or 2 years of relevant marketing data analysis and data base administration required
Experience in Microsoft Access database creation; proficient with related database maintenance and report writing 1 data query
Strong analytical skills a must
Experience in medical devices a plus
Ability to think outside the box and creatively analyze, interpret, and present data

When responding to this position please refer to job code: STF.520.012

Human Resources E-Mail: jchau@accuray.com

Human Resources Fax: 408-789-4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.

Patient Relations Manager

Thu, 01 Jan 1970 04:59:59 EST

Patient Relations Manager

Accuray™ Inc. is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a treatment to those diagnosed with cancer. It develops and markets the CyberKnife® System, the worlds first and only robotic radiosurgery system designed to treat tumors anywhere in the body with sub-millimeter accuracy. We are currently looking for a Patient Relations Manager to become a member of our dynamic team.

Responsibilities:

Support and manage the area of patient awareness, support, and education.
Educate the public regarding the benefits of radiosurgery and CyberKnife.
Create, facilitate, and moderate a medium for patients to interact with caregivers, other patients, prospective patients, and others.
Focus on patient specific content and deploy in appropriate media such as web, patient brochures, etc.
Coordinate, manage, facilitate and support the patient focused activities of Accuray.
Serve as patient and family advocate within Accuray.
Support and build relationships with existing cancer related patient support organizations.
Attend meetings and conferences focused on patient education and awareness.
Work with Marketing Communications to create synergies between DTC efforts and patient outreach. Increase visibility of CyberKnife throughout all media opportunities: Patient portraits, stories, spokespeople, patient magazines, radio stations, websites, etc.
Respond to emails and phone calls from prospective patients and family and direct them to the appropriate place.
Support CK Society efforts as they relate to patient advocacy and outreach activities.
Serve as primary liaison between patients and Accuray.
Stay knowledgeable regarding regulatory requirements and company policies such as HIPPA.

Qualifications:

MD required. (RN or Physician Assistant will also be considered.)
Must have prior medical and/or patient focused experience – CyberKnife experience is a plus
Must be able to think strategically and execute tactically while working alone and with a team
Must have excellent interpersonal skills with huge amounts of empathy and listening skills
Experience managing patient registry/database is a plus
Must have excellent writing, organization and project management skills
Non-profit experience is a plus
Must be located at Accuray Sunnyvale Headquarters
Public relations and general media experience is a plus
Ability to travel is a must

When responding to this position please refer to job code: STF.502.001

Human Resources E-Mail: jchau@accuray.com

Human Resources Phone: 408 789 4412

Accuray is an equal opportunity employer. Job postings at Accuray are for principal candidates only.