Senior R&D Product Development Systems Engineer - Medical Device
BUSINESS PROBLEM, CONTEXT & INITIATIVE DESCRIPTION
Our client is a privately held medical device company growing rapidly in the development of disease modifying therapies that improve survival, quality of life, and outcomes for patients with bronchitis and lung cancer.
The Senior R&D Engineer will contribute to the development of new pulsed-field energy delivery generator and disposable devices. This role includes technical contributions to the design and development projects and execution of the product verification and validation testing.
DUTIES / EXPECTATIONS OF THIS ROLE
• Contribute to the creation of design control inputs and design specifications required for next generation energy delivery generator.
• Manage consultants and/or contract manufacturer on detail design and development of next generation generator intended for commercial distribution per the Design Control Process.
• Support the design of components, sub-assembly, devices and software ensuring that all design requirements are met.
• Work with cross-functional resources to resolve design issues, define key characteristics, dimensional tolerances, manufacturing procedures, etc.
• Support process and test development through the design of fixtures and equipment.
• Present data and conclusions to support research and/or development activities.
• Write and review test protocols, reports and intellectual property.
• Provide technical support to Quality for CAPA investigations, complaints, and failure investigations.
• Provide technical support for Operations in developing and executing acceptance test protocols.
MUST HAVES - QUALIFICATION SUMMARY
· Bachelor's degree in Mechanical, Electrical, or Biomedical engineering
· 5 years' experience in Product Development within Medical Device industry
· Experience with either disposables or capital equipment
· Experience with the design controls processes. Understands risk management, documentation practices, human factors, software development and quality systems
· Experience with testing requirements for the development of medical devices; test method development, verification and validation. Experience with writing test method reports.
NICE-TO-HAVES - QUALIFICATION SUMMARY
• Pulse- Electrical Field Experience
TRAVEL & LOCATION
Onsite in Redwood City, CA
START & TERM
ASAP, 6–12-month contract-to-hire
“Skills, experience, and other compensable factors will be taken into account when determining pay rate. The pay range provided in this posting is a reflection of a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.”
“W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick me if required by law in the worked-in state/locality.”
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