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Systems Engineer IV

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POST DATE 9/13/2016
END DATE 1/17/2017

Varian Medical Systems, Inc. Milpitas, CA

Milpitas, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Position Title
Systems Engineer IV

Auto req ID

Business Unit Name
Particle Therapy



Job Type
Regular Full-Time

Job Description
The Systems Engineer will be responsible for the developments of Proton Therapy Products in accordance with the FDA Quality System Regulation (QSR) provisions for design controls. The Systems Engineer will be responsible for new product development projects with end-to-end management of 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.

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.

Job Requirements
Bachelor s degree (or equivalent experience) and 8 years of related experience or Master s Degree with 6 years of related experience.
Medical device development with risk analysis in accordance with ISO 14971 is highly preferred.
Experience with new product development for complex embedded systems.
Experience with SAP or equivalent ERP product and productivity software desired.

Percentage of Travel Required