Design Transfer SME
- Source: LinkedIn
- Katalyst CRO
- On-site
- Buffalo
- Mid level
Job Description
Summary 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.
Skills
- bridge
