Medical Device Engineer II
Company: Gateway Recruiting, INC.
Location: Mountain View
Posted on: March 19, 2023
- Establish and maintain design history file documentation for
development projects (design and development plan, requirements
specifications, device master record, IOV matrix, verification,
validation summary reports, etc.)
- Establish and maintain risk management documentation (risk
management plan, hazards analyses, failure mode, and effects
analyses) for development projects in accordance with ISO
- Coordinate product testing with vendors (e.g., mechanical shock
and vibration, environmental conditioning, ISTA 3A, battery tests,
IP22, etc.), including protocol development, sample coordination,
and writing test reports.
- Review deliverables from vendors, such as technical drawings,
technical reports, etc.
- Generate technical protocols and reports
- Develop validation master plans, IQ/OQ/PQ protocols, and
reports for test fixtures and manufacturing equipment
- Review mechanical drawings and electrical schematicsSkills
- Excellent technical writing skills
- Excellent mechanical aptitude and good attention to detail
- Excellent oral and written communication skills as well as
strong interpersonal skills
- Well-versed in FDA regulations for medical devices and products
including Design Controls 21 CFR 820 and MDR
- Experience working in compliance with GMP regulations
- Experience with mechanical drawings and electrical schematics
preferred -Education and Experience:
- Bachelor's or higher-level STEAM degree, Physics, or related
field, or demonstrated equivalent experience
- 2+ years of product development experience in medical device
- Prolonged periods of sitting at a desk and working on a
- Must be able to lift up to 15 pounds at times
- Must be willing to travelPowered by JazzHR
Keywords: Gateway Recruiting, INC., Mountain View , Medical Device Engineer II, Healthcare , Mountain View, California
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