Senior Design Quality Assurance Engineer

PurposeAs a Senior Design Quality Assurance Engineer, you will lead Design Assurance activities for new product development and lifecycle projects. You will work closely with R&D and cross‑functional teams to ensure products meet global quality and regulatory standards. This role offers the opportunity to support innovation, drive quality improvements, and influence processes across the organization. You will be involved in multiple ongoing projects, including consumables manufactured in Mexico and the UK, as well as new product design and change initiatives.Key ResponsibilitiesLead design assurance activities for new product development and sustaining engineering projectsWork closely with R&D (about 10 engineers) on design, testing, and verification activitiesSupport design reviews, verification & validation, usability testing, and Design History FilesLead risk management activities including FMEA, risk mitigation, and effectiveness checksSupport design transfer, process validation, and test method validationCollaborate with Regulatory, Supply Chain, Manufacturing, and Quality teamsParticipate in audits, CAPA boards, and complaint review boardsSupport regulatory submissions and defend design controls in internal and external auditsTrack and support multiple change initiatives (~60 ongoing), including sourcing new componentsDrive continuous improvement in quality and design assurance processesQualifications5+ years of experience in the medical device industry (Design Assurance, Quality, or Product Development)Strong knowledge of new product development and close collaboration with R&DSolid understanding of global regulations and standards: FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366Experience working with cross‑functional and global teamsBachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related fieldProactive, detail‑oriented, and solution‑drivenProficiency in Microsoft Office; experience with Minitab or similar tools a plusMust be based in Boston areaSenior‑level experience requiredCompanyBVI® is refocusing the future of vision. As one of the fastest‑growing, diversified surgical ophthalmic businesses in the world, our purpose‑built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single‑Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries. We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.Learn more at www.bvimedical.com#J-18808-Ljbffr