Design Transfer SME / Technical Lead – Medical Devices

Key Responsibilities

• Lead Design Transfer and Design Control activities
• Bridge R&D, Systems, Mechanical, Manufacturing, and Quality teams
• Develop and optimize manufacturing processes and assembly methods
• Build and troubleshoot pilot units
• Identify design, tooling, and assembly risks before production scale-up
• Drive manufacturing readiness from prototype through pilot to high-volume production
• Develop DMRs, work instructions, and manufacturing documentation
• Resolve complex manufacturing and assembly issues
• Serve as the technical decision-maker and engineering liaison

Required Qualifications

• 12+ years of Medical Device experience
• Design Control and Design Transfer expertise
• Proven leadership of complex electromechanical medical device transfers
• Pilot Manufacturing and Manufacturing Readiness experience
• Product Development and Manufacturing Engineering background
• Manufacturing Process Development and Optimization experience
• Experience with DMR, Work Instructions, and Assembly Procedures
• Mechanical and systems-level assembly troubleshooting skills
• FDA / ISO 13485 / Design Control knowledge
• Strong R&D, Manufacturing, and Quality leadership experience