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Magenta Medical is seeking a Process Quality Engineer to join its QA team and support the scaling of manufacturing for an innovative Class III medical device. This role bridges quality assurance, regulatory compliance, and cross-functional collaboration in a growing medtech organization.
Key responsibilities include leading and ensuring quality of new product introduction (NPI) and manufacturing processes; leading and supporting process validation activities (IQ/OQ/PQ); reviewing and approving work instructions, assembly instructions, manufacturing specifications, validation protocols, and technical drawings created in SolidWorks; managing Change Control processes; and providing professional guidance to R&D, Engineering, and Manufacturing teams on quality and manufacturing requirements.
You will collaborate closely with R&D, Engineering, and Manufacturing to implement process changes, drive continuous improvements, and ensure product quality. The role requires identifying and leading continuous improvement initiatives in NPI and manufacturing while ensuring compliance with ISO 13485 standards and FDA regulatory requirements. You will provide QA oversight and support for Design Transfer and NPI activities, ensuring smooth and compliant transition of products from development to manufacturing.
The ideal candidate holds a B.Sc. in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related discipline, with 2–4 years of experience as an engineer in the medical device industry. Required experience includes hands-on process validation (IQ/OQ/PQ), Design Transfer/NPI activities, Change Control processes, and mechanical CAD (SolidWorks). You should be able to independently lead projects, drive cross-functional processes, and demonstrate strong self-learning capability, interpersonal skills, and communication. Reports to QA Manager.
