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Senior Manufacturing Engineer – Console Process Development
Overview
Our client is scaling production of a combination product console Delivery System and needs a senior-level manufacturing engineer to lead console process development. This role focuses on turning R&D designs into robust, compliant, and cost-effective production processes while supporting NPIs, validation, and continuous improvement in a regulated medical-device environment.
Responsibilities
Lead development, validation and scale-up of manufacturing and servicing processes for the nitric oxide combination product console. Own IQ/OQ/PQ and change-control activities; drive DFM and handoffs with R&D; select and qualify equipment, tooling and fixtures; lead root-cause investigations and CAPA; implement Lean/Six Sigma improvements to raise yield, reduce cycle time and lower cost; partner with Quality, Regulatory, Operations, Supply Chain and vendors to deliver production-ready processes.
Required Skills
- Bachelor’s in Mechanical, Electrical, Industrial, Biomedical engineering or related (MS preferred).
- 5–8+ years in manufacturing/process engineering in medical device or other regulated industry.
- Proven experience with process development, IQ/OQ/PQ and NPI.
- Knowledge of FDA QSR, ISO 13485 and GMP.
- Proficiency with statistical tools (Minitab/JMP), FMEA, and Lean/Six Sigma methods.
- Hands‑on experience with equipment selection, tooling/fixture design, and DFM.
- SolidWorks (or equivalent), GD&T, and familiarity with pneumatic/fluidic schematics.
- Experience supporting automation, robotics or advanced manufacturing technologies a plus.
- Strong project management, documentation, and cross‑functional communication skills.
- Practical, hands‑on mindset with ability to mentor peers and drive results under changing priorities.