Note: The job is a remote job and is open to candidates in USA. QvalFocus Inc. is seeking a Design Transfer Engineer to lead and coordinate design transfer activities for a complex imaging medical device platform. This role involves ensuring alignment between product design, system verification/validation, and manufacturing processes to support successful commercialization.

Responsibilities

• Lead design transfer and commercialization activities for a next generation imaging medical device platform
• Coordinate cross functional alignment between product development, manufacturing engineering, quality, and operations teams
• Drive review and completion of manufacturing transfer deliverables, including BOMs, manufacturing procedures, assembly instructions, test methods, and production readiness documentation
• Ensure traceability between design inputs, outputs, verification/validation activities, and manufacturing documentation
• Identify and mitigate risks associated with product transfer, manufacturing scalability, and production readiness
• Collaborate with Software, Hardware, Embedded, and Systems Engineering teams to ensure design changes are appropriately evaluated and transferred into manufacturing documentation
• Support resolution of design transfer gaps, manufacturing deviations, and commercialization readiness issues
• Participate in design reviews, risk assessments, and product realization activities throughout the product lifecycle
• Coordinate with Verification & Validation teams to ensure manufacturing test methods and acceptance criteria are aligned with product requirements
• Support FDA/ISO 13485 design control compliance and ensure design transfer activities align with IEC 62304, ISO 14971, and applicable medical device regulations
• Partner with suppliers, manufacturing partners, and operations teams to support pilot builds, process validation, and production ramp-up activities. Support development and execution of remediation or enhancement strategies where gaps in transfer or manufacturing documentation are identified

Skills

• 10+ years of experience in medical device product development, design transfer, or commercialization
• Strong experience supporting New Product Development (NPD) through commercialization for complex medical devices
• Strong understanding of design transfer, product realization, and manufacturing readiness processes
• Experience with DHF, DMR, manufacturing documentation, and design control requirements
• Experience collaborating with Systems, Software, Hardware, Embedded, Manufacturing, and Quality Engineering teams
• Familiarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971
• Experience supporting pilot builds, process validation, verification/validation alignment, and production release activities
• Strong leadership, communication, and cross-functional coordination skills
• Bachelor's or Master's degree in Engineering or related technical discipline
• Experience working with imaging systems, electromechanical systems, diagnostic instruments, or capital medical equipment preferred
• Experience in remediation, gap assessment, or retrospective design transfer review activities is a plus

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