About this role
Manufacturing Mechanical Engineer IV at BiVACOR. Location: Huntington Beach, California, United States. Role: leading manufacturing, conducting validation, mentoring engineers Requirements: BS in engineering required (MS desirable), 8+ years manufacturing/process development experience in medical device or regulated industry, deep expertise in validation (IQ/OQ/PQ/PPQ), pFMEA, TMVs, ISO 13485 and GMP, Six Sigma Black Belt and PMP preferred, mentoring experience. Category: Engineering Seniority: Senior Level Tools: Lean, Six Sigma, pFMEA, MVP, IQ, OQ, PQ, PPQ, TMV, Design for Manufacturability (DFM), ISO 13485, GMP, CAPA, FDA Certifications: six sigma black belt, pmp Commitment: Full Time Workplace: Onsite Languages: English