Senior Design Quality Assurance Engineer

Job

Requisition Name

Senior Design Quality Assurance Engineer

Job

Requisition No

VN8408

Work Location Name

USA - Waltham

Worker Basis

Full Time

Worker Type

Employee

Contract Type

Permanent

Applications Close Date

Dec 31, 2026

Purpose

As a Senior Design Quality Assurance Engineer, you will provide multi-site leadership and oversight for Design Assurance activities across new product development and lifecycle management projects. You will play a key role in ensuring compliance with global quality and regulatory standards while partnering with cross-functional teams to drive product quality and performance.

This role offers the opportunity to influence global processes, support innovation, and contribute to building a strong quality culture across the organization.

* Lead Design Assurance activities across multiple sites for new product development and sustaining engineering projects

* Provide technical guidance on design controls, risk management, and quality strategies

* Support the development, implementation, and continuous improvement of Design Controls and Risk Management processes

* Lead and support risk management activities, including FMEA, risk mitigation, and verification of effectiveness

* Collaborate with cross-functional teams (R&D, Regulatory, Supply Chain, Manufacturing) to ensure compliance and project success

* Support design reviews, verification, validation, usability testing, and Design History File (DHF) activities

* Contribute to design transfer activities, including test method validation, measurement systems analysis, and process validation

* Participate in audits, CAPA Review Boards, and Complaint Review Boards, providing Design Assurance expertise

* Support regulatory submissions and defend design control elements during internal and external audits, including gap assessments

* Identify and drive continuous improvement initiatives across QMS processes and support broader quality activities (e.g., Supplier Quality, Post-Market Surveillance, EU MDR remediation)

* 5+ years of experience in medical device engineering, ideally within Design Assurance, Quality, or product development environments

* Strong knowledge of Design Controls, Risk Management, and product development processes

* Solid understanding of global regulations and standards (FDA 21 CFR, EU MDR/MDD, ISO 13485, ISO 14971, IEC 60601, IEC 62366)

* Experience working in cross-functional and global teams

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

* Fluency in English (written and spoken)

* Strong communication and stakeholder management skills

* Proactive, detail-oriented, and solution-driven mindset

* Proficiency in Microsoft Office Suite

* Experience with Minitab or similar statistical tools

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