Design Transfer Lead – Medical Devices & Manufacturing
Katalyst CRO
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Job summary
Katalyst CRO is seeking a senior Design Transfer SME / Technical Lead to steer the transition of complex medical devices from R&D through Pilot Manufacturing to Production in Buffalo, NY. You will serve as a technical decision-maker across engineering, manufacturing, and quality teams.
The ideal candidate has extensive experience with design transfer, design control, and manufacturing readiness, leading cross-functional efforts to ensure successful commercialization of sophisticated
Qualifications
- 12+ years Medical Device experience.
- Proven leadership of complex electromechanical medical device transfers.
- Pilot Manufacturing & Manufacturing Readiness.
- Product Development & Manufacturing Engineering.
- DMR, Work Instructions & Assembly Procedures.
- Mechanical & Systems-Level Assembly Troubleshooting.
- FDA / ISO 13485 / Design Control knowledge.
Responsibilities
- 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.
Skills
Education
Tools
Job description
Katalyst CRO is seeking a senior Design Transfer SME / Technical Lead to steer the transition of complex medical devices from R&D through Pilot Manufacturing to Production in Buffalo, NY. You will serve as a technical decision-maker across engineering, manufacturing, and quality teams.
The ideal candidate has extensive experience with design transfer, design control, and manufacturing readiness, leading cross-functional efforts to ensure successful commercialization of sophisticated
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