Senior Design Quality Engineer

Purpose

As a Senior Design Quality Engineer, you will play a pivotal role in supporting multi-site teams and providing engineering support across new product development and lifecycle management projects. You will contribute to the deployment and application of Design Controls procedures, ensuring that projects are appropriately resourced and aligned with key milestones. In this role, you will collaborate with peers and senior leaders in functions such as Research & Development, Regulatory, Marketing, Supply Chain, and Manufacturing Operations. Additionally, you will support various aspects of the Quality Management System (QMS), including Quality Systems, Post Market Surveillance, and Supplier Quality.

Key Responsibilities

• Lead Design Assurance teams across multiple sites on major product development and sustaining engineering projects
• Coach, mentor, and develop team members; support career growth, recruitment, and performance management
• Define and implement departmental strategies to support product performance and innovation
• Develop, maintain, and train global teams on state-of-the-art Design Controls and Risk Management procedures to ensure compliance
• Collaborate with Quality leadership to enhance QMS maturity; support audits, CAPA and Complaint Review Boards
• Foster cross-functional partnerships to strengthen Quality culture and position Quality as a strategic advantage
• Provide technical guidance and help resolve complex design and quality issues
• Support EU MDR remediation efforts and lead design control gap assessments (e.g., DHF audits)
• Oversee risk management planning, FMEAs, risk mitigation, and effectiveness verification
• Ensure quality design transfer, including test method validation, process validations, and incoming inspection readiness
• Contribute to the creation and audit of design documentation, including DHF and DMR components
• Provide quality input throughout the design lifecycle, including user needs, design inputs/outputs, and critical-to-quality elements
• Support design verification, validation, usability testing, and regulatory submission preparation
• Lead or support quality improvement initiatives across sites and functions
• Assist with broader QMS responsibilities, including Post Market Surveillance and Supplier Quality

Requirements

• Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering
• Minimum 5 years of engineering experience ( preferably in the medical device industry)
• In-depth familiarity with FDA, ISO, MDD/MDR, and medical device industry quality requirements associated with product development, design controls, and product risk management
• Detailed understanding and working knowledge of U.S. and international regulations, including 21 CFR 820, 803, 50, and 11, as well as the Medical Device Directive/Medical Device Regulation, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366
• Proficient in Microsoft Office Suite
• Experience with Minitab or equivalent statistical analysis software
• Strong communication and presentation skills

CompanyBVI® 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