Manufacturing Engineer
Listed on 2026-01-12
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Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer, Lean Manufacturing / Six Sigma -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Lean Manufacturing / Six Sigma
Staff Manufacturing Engineer
A growing medical device organization is seeking a Staff Manufacturing Engineer to serve as a senior technical contributor within manufacturing and process development. This role plays a critical part in supporting complex medical device production, driving process improvements, and ensuring scalable, high-quality manufacturing operations.
The ideal candidate is a hands‑on technical leader with deep experience in regulated environments who can partner cross‑functionally to bring robust manufacturing solutions from development through production.
Key Responsibilities- Lead development, optimization, and sustainment of manufacturing processes for complex medical devices
- Serve as a technical expert supporting production, NPI, and continuous improvement initiatives
- Drive process characterization, validation activities (IQ/OQ/PQ), and documentation in compliance with quality and regulatory standards
- Identify manufacturing risks and implement corrective and preventive actions
- Collaborate closely with Quality, R&D, Operations, and Supply Chain teams to ensure smooth design transfer and manufacturing readiness
- Support equipment selection, tooling development, and vendor management as needed
- Mentor junior engineers and provide technical guidance across manufacturing teams
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, or related field)
- 8+ years of experience in manufacturing or process engineering within the medical device industry
- Strong knowledge of regulated manufacturing environments (FDA, ISO 13485, GMP)
- Experience with process validation, continuous improvement, and root cause analysis
- Proven ability to work cross‑functionally and lead technical initiatives
- Excellent communication skills and a proactive, problem‑solving mindset
This is a high-impact opportunity for a senior engineer who enjoys owning technical challenges, influencing manufacturing strategy, and contributing directly to the success of life‑saving medical technologies—while remaining deeply hands‑on.
Seniority levelMid‑Senior level
Employment typeFull‑time
Job functionManufacturing
IndustriesMedical Equipment Manufacturing
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