Design Quality Engineer – New Product Development

Design Quality Engineer – New Product DevelopmentAbout the RoleDepartment: Quality AssuranceReports to: QMR / Head of QualityAcrostak is a global leader in health technology, committed to improving hundreds of thousands of lives worldwide and striving to make the world healthier and more sustainable through optimized manufacturing and innovation.This position is primarily focused on supporting new product development activities (approximately 80% of the role), partnering closely with R&D, Manufacturing engineering, and Production teams to ensure quality and regulatory requirements are embedded early and throughout the design lifecycle. You will serve as a Design & Development Quality partner, providing oversight, guidance, and risk-based decision-making to support successful product commercialization.Key ResponsibilitiesWrite, review and approve design and development documents, including design inputs, outputs, verification, validation, and design transfer activitiesEnsure compliance with FDA Quality System Regulation (21 CFR 820), Medical Device Reporting requirements (21 CFR 803), ISO, and internal quality system requirementsDefine, review and approve sample size rationales for design verification, validation, and process validation activities to ensure statistical adequacy.Participate in design reviews, risk management activities, and cross-functional technical discussions to ensure quality and patient safety considerations are addressedCollaborate with R&D, Engineering, Manufacturing, Product Safety, and Suppliers to support both development and post-market investigations.RequirementsBachelor’s degree in engineering, Life Sciences, or a related technical discipline.5+ years of Quality experience in the medical device industry, with significant involvement in design and development or new product introduction (NPI)Strong working knowledge of design controls, risk management, and development-phase quality requirements under FDA QSR and ISODemonstrated ability to partner effectively with R&D and Engineering teams, providing practical, risk-based Quality guidanceSwiss work permit / European citizenship.Working experience with Greenlight Guru eQMS – an advantage.What we are looking for in a candidateTeam-player mentality and ability to deliver on a tight schedule.Strong interpersonal and communication skills — maintaining excellent working relationships with other departments while coordinating toward timely goal completion.Apply a balanced, pragmatic approach that supports regulatory requirements while pushing development efficiency and product timelines.What we offerDynamic working environment with plenty of room to grow and take initiative. You will take part in all stages of the design and development process, from concept to commercialized product, working on technologies aimed at treating vascular diseases. European or Swiss work authorization is a precondition of employment.The company will not consider candidates who require sponsorship for a work-authorized visa. jid50ea077a jit0310a jiy26a