Location: Rancho Cordova CA
Duration: 5 Months
More than 10 years professional experience in the applicable role.
Bachelor's /Master's degree in Engineering.
Expert and technical lead with proven experience.
Expert on manufacturing process flow and design transfer, Lead manufacturing fixture development, process development and qualifications, lead process development and optimization of critical fabrication, maintain manufacturing specifications, requirements, and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents, expert technical lead on design transfer in partnership with contract manufacturers, ensure document management and manufacturing control compliance.
Conduct and manage structured design reviews.
Strong Solid Works background for fixture and equipment design.
Works with hardware, software and firmware engineers, and system engineers, guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing.
Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business.
Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices.
Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment.