Design Transfer SME
Job in
Buffalo, Erie County, New York, 14201, USA
Listed on 2026-08-22
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-08-22
Job specializations:
-
Manufacturing / Production
Manufacturing Engineer, Medical Device Industry, Quality Engineering, Product Engineer -
Engineering
Manufacturing Engineer, Medical Device Industry, Quality Engineering, Product Engineer
Job Description & How to Apply Below
Senior-Level Design Transfer Sme / Technical Lead
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
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