Senior Manufacturing Engineer

This range is provided by ALKU. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Senior Manufacturing Engineer – Console Process Development

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.

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.

• 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.
• Solid Works (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.