Senior Design Quality Assurance Engineer

BVI Medical; Waltham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading surgical ophthalmic company in Waltham, MA is seeking a Senior Design Quality Assurance Engineer. You will lead activities for new product development, ensuring compliance with global quality and regulatory standards. The role involves collaboration with R&D and cross-functional teams, managing risk, and supporting regulatory submissions. Ideal candidates have over 5 years of experience in the medical device industry, a background in engineering, and are detail-oriented problem solvers.

Qualifications

• 5+ years of experience in the medical device industry.
• Strong knowledge of new product development.
• Solid understanding of global regulations and standards.

Responsibilities

• Lead design assurance activities for new product development.
• Collaborate with R&D on design, testing, and verification.
• Support regulatory submissions and audits.

Skills

Experience in the medical device industry

Collaboration with R&D

Understanding of global regulations

Proficient in Microsoft Office

Education

Bachelor's degree in Mechanical, Electrical, Biomedical Engineering or related field

Tools

Minitab

Job description

Purpose

As 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 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

Qualifications

• 5+ 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&D
• Solid understanding of global regulations and standards: FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366
• Experience working with cross‑functional and global teams
• 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
• Must be based in Boston area
• Senior‑level experience required

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® (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