Systems Engineer IV 9/13/2016
Varian Medical Systems, Inc.
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Systems Engineer IV
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Systems Engineering with new product development projects experience doing end-to-end requirements management for complex, medium to large scale interactive embedded systems with traceability from product specification level through hardware and software specifications to completion of the verification and validation with the integrated equipment. Emphasis will be on requirements development for the Proton Therapy Product in accordance with the FDA Quality System Regulation (QSR) provisions for design controls, so experience that includes medical devices development with risk analysis in accordance with ISO 14971 is preferred. Principal Duties and Responsibilities (Essential Functions**): Translate customer inputs into system requirements using formal specification language. Allocate system requirements into subsystem hardware and software requirements. Assign trace links with the DOORS requirements management tool. Perform hazard analyses to develop risk control measures associated requirements. Review and assist development of V&V procedures by quality engineering. Assist development of project associated procedures and instructions. Review associated engineering documentation. Assist development of subsystem service manuals. Assist development of FDA 510(k) submittal content.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability.
Minimum Required Skills and Knowledge:
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP or equivalent ERP product and productivity software desired.
Typical Education and Experience:
Bachelors degree (or equivalent experience) and 8 years of related experience or Masters Degree with 6 years of related experience.
Percentage of Travel Required