Design Transfer SME

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

Job summary

Creative Solutions Services, LLC seeks a senior Design Transfer SME / Technical Lead to steer complex medical devices from R&D to Pilot Manufacturing and Production. The role emphasizes technical decision-making across electromechanical devices, software-enabled and AI-driven systems, with a focus on commercialization readiness.

The ideal candidate will bridge R&D, systems, mechanical, manufacturing and quality teams, driving design transfer, risk mitigation, and manufacturing documentation to

Qualifications

• 12+ years of 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.

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 to pilot to 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

Design Control

Systems Engineering

Manufacturing Readiness

Leadership

Engineering Liaison

Risk Identification

Cross-Functional Leadership

Education

Advanced Engineering Degree

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 to Pilot Manufacturing to 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 to pilot to 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.