Senior Design Quality Assurance Engineer

Key Responsibilities

• Lead design assurance activities for new product development and sustaining engineering projects
• Work closely with R&D (about 10 engineers) on design, testing, and verification activities
• Support design reviews, verification & validation, usability testing, and Design History Files
• Lead risk management activities including FMEA, risk mitigation, and effectiveness checks
• Support design transfer, process validation, and test method validation
• Collaborate with Regulatory, Supply Chain, Manufacturing, and Quality teams
• Participate in audits, CAPA boards, and complaint review boards
• Support regulatory submissions and defend design controls in internal and external audits
• Track and support multiple change initiatives (~60 ongoing), including sourcing new components
• Drive continuous improvement in quality and design assurance processes

Qualification

• 5+ years of experience in the medical device industry (Design Assurance, Quality, or Product Development)
• Solid understanding of global regulations and standards: FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366
• Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or related field
• Proactive, detail-oriented, and solution-driven
• Proficiency in Microsoft Office; experience with Minitab or similar tools a plus

About the Role

This role offers the opportunity to support innovation, drive quality improvements, and influence processes across the organization.

Benefits

Company BVI® 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®, Visitec®, Malosa®, Vitreq®, and PhysIOL®. 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.

Pay

N/A

Schedule

N/A

Skills

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 62366Proactive, detail-oriented, and solution-drivenProficiency in Microsoft Office; experience with Minitab or similar tools a plus