More jobs:
Manufacturing Engineer
Job in
Duluth, St. Louis County, Minnesota, 55806, USA
Listed on 2026-06-02
Listing for:
Novozen Healthcare LLC
Full Time
position Listed on 2026-06-02
Job specializations:
-
Manufacturing / Production
Manufacturing Engineer, Quality Engineering -
Engineering
Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Manufacturing Engineer – NPI (Medical Device)
We are hiring a Manufacturing Engineer with strong New Product Introduction (NPI) experience to support the successful transfer of medical device products from design to manufacturing. This role requires hands‑on expertise in process development, validation, and working within regulated environments.
Key Responsibilities- Lead NPI activities including process development, equipment selection, and production readiness
- Collaborate with R&D, Quality, and Supply Chain teams for smooth product transfer
- Develop and optimize manufacturing processes, work instructions, and SOPs
- Execute process validations (IQ/OQ/PQ) and support equipment qualification
- Support pilot builds, engineering runs, and scale‑up to full production
- Troubleshoot manufacturing issues and drive continuous improvement initiatives
- Ensure compliance with GMP, FDA, and ISO 13485 standards
- Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related field
- 5–6 years of experience in medical device manufacturing
- Strong hands‑on experience in NPI and process validation
- Knowledge of GMP, FDA regulations, and ISO standards
- Experience in high‑volume or automated manufacturing environments is preferred
- Problem‑solving and root cause analysis
- Cross‑functional collaboration
- Lean Manufacturing / Six Sigma (preferred)
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