We are looking for a Medical Device Process Engineer to be in the Fremont, CA area. This is a hands-on assignment involving a team of talented electrical, software and mechanical engineers solving tough technical problems. You will be responsible for making design proposals, reporting progress, and maintaining a strong relationship with our customers.
Target Skill Set:
• BS or MS in Engineering from an accredited university
• 5+ years professional experience in late stage product development, new product introductions, or manufacturing engineering for medical devices
• Experience with drug-device combination products preferred
• Guide in design control deliverables including design transfer, test method validation, risk assessment, protocol and validation report writing
• Maintain, Validate and Release Test Systems in Production Environment
• Knowledge of various quality and FDA standards such as, ISO 9000, 13485 and CAPAs
• Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices
• Experience in PFMEA, Gage R&R, test systems and manufacturing software validation
• Write and maintain FDA level validation protocols and reports
• Must be legally authorized to work in the U.S. without sponsorship
Why join the Andrews-Cooper team?
• Andrews-Cooper is an established growing 85+ person company with an 18+year track record of design excellence
• This is a full-time position with great benefits including competitive wages with incentive compensation, medical, dental and life insurance, company 401k w/ match, & professional development.
• You will experience a wide variety of engineering challenges and work with a team of A-player engineers
• We appreciate passionate self-starters who want to make a difference
• Andrews-Cooper is an equal opportunity employer