Manufacturing Engineer

An established global medical device manufacturer is seeking a Senior Manufacturing Engineer to lead high-impact process improvements, support new product introductions, and drive quality and reliability in a regulated production environment.

This is a highly visible role within a growing, innovation-driven organization whose products directly support critical healthcare and transfusion applications.

• Lead complex manufacturing projects from concept through implementation
• Drive quality, cost, and efficiency improvements across production processes
• Own out-of-box and early-life product performance for a key product line
• Execute and document process validations (IQ/OQ/PQ)
• Lead or support Lean / Six Sigma / Kaizen initiatives
• Conduct and maintain dFMEA / pFMEA and risk management documentation
• Ensure compliance with ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR
• Support design transfer, scale-up, and new product introduction
• Partner cross-functionally with R&D, Quality, and Operations

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Chemical, Materials, or similar)
• 5+ years of manufacturing engineering experience in an FDA-regulated industry
• Experience in medium-to-high volume manufacturing environments
• Strong background in process validation and continuous improvement
• Experience with statistical tools (Minitab, JMP)
• Familiarity with CAD (Solid Works or Pro/E preferred)
• Knowledge of ISO 13485 and ISO 14971
• Transfusion or blood-handling device experience highly preferred

• Direct impact on patient safety and product reliability
• Strong cross-functional exposure and leadership visibility
• Opportunity to influence design-for-manufacturability and scale-up strategy
• Stable, global organization with continued investment in innovation

If you’re an experienced manufacturing engineer who thrives in regulated environments and enjoys solving complex process challenges, I welcome a confidential conversation.