[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.ResponsibilitiesLead design transfer and commercialization activities for a next generation imaging medical device platformCoordinate cross functional alignment between product development, manufacturing engineering, quality, and operations teamsDrive review and completion of manufacturing transfer deliverables, including BOMs, manufacturing procedures, assembly instructions, test methods, and production readiness documentationEnsure traceability between design inputs, outputs, verification/validation activities, and manufacturing documentationIdentify and mitigate risks associated with product transfer, manufacturing scalability, and production readinessCollaborate with Software, Hardware, Embedded, and Systems Engineering teams to ensure design changes are appropriately evaluated and transferred into manufacturing documentationSupport resolution of design transfer gaps, manufacturing deviations, and commercialization readiness issuesParticipate in design reviews, risk assessments, and product realization activities throughout the product lifecycleCoordinate with Verification & Validation teams to ensure manufacturing test methods and acceptance criteria are aligned with product requirementsSupport FDA/ISO 13485 design control compliance and ensure design transfer activities align with IEC 62304, ISO 14971, and applicable medical device regulationsPartner 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 identifiedSkills10+ years of experience in medical device product development, design transfer, or commercializationStrong experience supporting New Product Development (NPD) through commercialization for complex medical devicesStrong understanding of design transfer, product realization, and manufacturing readiness processesExperience with DHF, DMR, manufacturing documentation, and design control requirementsExperience collaborating with Systems, Software, Hardware, Embedded, Manufacturing, and Quality Engineering teamsFamiliarity with FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971Experience supporting pilot builds, process validation, verification/validation alignment, and production release activitiesStrong leadership, communication, and cross-functional coordination skillsBachelor's or Master's degree in Engineering or related technical disciplineExperience working with imaging systems, electromechanical systems, diagnostic instruments, or capital medical equipment preferredExperience in remediation, gap assessment, or retrospective design transfer review activities is a plusCompany OverviewQvalFocus: 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 SponsorshipQvalFocus 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.