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[Remote] Design Transfer Engineer
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 Company Overview QvalFocus Focused on Delivering Quality that sets us Apart. It was founded in 2024, and is headquartered in Plainsboro, New Jersey, USA, with a workforce of 51-200 employees. Its website is https//qvalfocus.com. Company H1B Sponsorship QvalFocus Inc. has a track record of offering H1B sponsorships, with 10 in 2026, 33 in 2025, 18 in 2024. Please note that this does not guarantee sponsorship for this specific role.
