Title: Medical Device Engineer III
Location: Mountain View, CA (Hybrid – in office and remote)
Term: 6-month contract (potential for extension and/or conversion)
Pay: $120,000/ year (Weekly pay)
- Establish and maintain design history file documentation for development projects (design and development plan, requirements specifications, device master record, IOV matrix, verification and 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 14971
- 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 and maintain technical specifications for product components
- Coordinate activities required to get parts & suppliers added to ASL
- Generate technical protocols and reports
- Develop validation master plans, IQ/OQ/PQ protocols and reports for test fixtures and manufacturing equipment
- Excellent mechanical aptitude and good attention to details
- Experience designing and troubleshooting electronic and mechanical systems
- Experience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferred
- Experience in designing injection molded parts preferred
- Excellent oral and written communication skills as well as strong interpersonal skills
- Experience programming in LabVIEW a plus
- 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
Education and Experience
- Bachelor’s or higher-level STEM degree, Physics or related field, or demonstrated equivalent experience
- 5+ years’ product development experience in medical device
Please submit your resume for consideration!
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