Design Transfer SME

We are seeking a senior-level Design Transfer SME / Technical Lead to lead the transition of complex medical devices from R&D → Pilot Manufacturing → Production.

The ideal candidate is a strong technical decision-maker with experience bringing complex electromechanical medical devices from engineering through commercialization.

Roles & Responsibilities:

• Diagnostic Imaging / Capital Equipment.
• Complex Electromechanical Medical Devices.
• Software-Enabled Medical Devices.
• AI-Driven Medical Devices.
• Systems Engineering / Product Commercialization.
• Advanced Engineering Degree.
• Lead Design Transfer & Design Control activities.
• Bridge R&D, Systems, Mechanical, Manufacturing & 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 → pilot → 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.

Requirements:

• 12+ years Medical Device experience.
• Design Control & Design Transfer expertise.
• Proven leadership of complex electromechanical medical device transfers.
• Pilot Manufacturing & Manufacturing Readiness.
• Product Development & Manufacturing Engineering.
• Manufacturing Process Development & Optimization.
• DMR, Work Instructions & Assembly Procedures.
• Mechanical & Systems-Level Assembly Troubleshooting.
• FDA / ISO 13485 / Design Control knowledge.
• Strong R&D, Manufacturing & Quality leadership.