Sr. Process & Operations Engineer
United States
Workplace: OnsiteFull timeUSD 130,000 - 150,000 annuallyFunction: Communications, PR & CommunityExperience: 8+ yearsEducation: bachelorsSkills: ["Cross-functional collaboration","Root cause analysis","Process optimization","Continuous improvement"]Oversee contract manufacturing for a Class II FDA-regulated medical device, serving as the primary technical liaison between internal teams and CMOs. Lead day-to-day manufacturing performance, quality metrics, and execution while developing and validating manufacturing processes (including IQ/OQ/PQ), supporting design transfer, and driving CAPAs. Ensure compliance with 21 CFR Part 820, ISO 13485, and GMP, collaborate with R&D/Quality/Regulatory/Supply Chain, and drive continuous improvement using Lean and Six Sigma.
