Design Transfer SME

Katalyst CRO; Buffalo (NY); On-site; USD 140,000 - 190,000; Full time

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

Design Transfer

Leadership

Systems Engineering

Regulatory Knowledge

Product Commercialization

Education

Advanced Engineering Degree

Tools

Design Control Tools

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.