Manufacturing Engineer - Medical Device

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Hiring for Manufacturing Engineer - Medical Device / Regulated Manufacturing in St Paul, Minnesota,

Industry: Medical Device / Regulated Manufacturing

We are seeking a results-driven Manufacturing Engineer to support process development, yield improvement, equipment qualification, and new product introductions within a regulated medical device environment. The ideal candidate will have strong DOE experience, Lean manufacturing expertise, and FDA-compliant manufacturing knowledge.

• Develop and establish manufacturing processes based on product specifications and DFM principles
• Run Design of Experiments (DOE) to improve yield and efficiency
• Conduct equipment qualification and process validation (IQ/OQ/PQ)
• Lead projects involving new production equipment, tooling, and process improvements
• Drive cost reduction initiatives and understand Cost of Goods Sold (COGS)
• Apply Lean Manufacturing and DMAIC tools to improve quality and throughput
• Coordinate design, procurement, build, and debugging of tooling and test equipment
• Partner cross-functionally with R&D, Quality, Finance, and Operations
• Ensure compliance with FDA regulations
  , QMS, EMS, and OSHA standards
• Mentor and coach technicians, operators, and trainers
• Support divisional and company-wide quality initiatives

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Required Qualifications

• Bachelor’s Degree in Chemical, Mechanical, Industrial Engineering or related field
• 5+ years of Manufacturing Engineering experience in medical device or regulated industry
• Hands‑on experience with DOE, process validation, and equipment qualification
• Strong knowledge of FDA regulations, QMS, and Design Controls
• Experience in matrixed, cross‑functional environments
• Strong analytical, problem‑solving, and project management skills
• Proficient in MS Office Suite
• Medical device manufacturing experience
• Experience partnering closely with R&D
• Delivery system/process yield improvement experience
• Lean Six Sigma Green or Black Belt certification