Design Quality Assurance Engineer III - Endoscopy

Additional Location(s): N/A

Diversity
- Innovation
- Caring
- Global Collaboration
- Winning Spirit
- High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

The Design Quality Assurance Engineer III provides quality engineering support and expertise across the product lifecycle, including new product development, design transfer, product changes, sustaining engineering, material continuity, regulatory compliance, corrective and preventive actions, and post-market support activities. Working in a fast-paced cross-functional environment, this role partners with Research & Development, Operations, Supplier Quality, Manufacturing, Regulatory Affairs, Clinical, and Marketing teams to ensure products are safe, effective, compliant, and meet customer and business needs.

The engineer serves as a quality representative, championing patient safety, product quality, risk-based decision making, and continuous improvement.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Marlborough, MA and requires being on-site at least three (3) days per week.

Relocation assistance may be available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time

• Provide quality engineering support for new product development, product enhancements, design transfers, design changes, and sustaining engineering projects.

• Partner with cross-functional teams to ensure compliance with Product Development Process, Design Controls, Risk Management, and applicable Quality System requirements.

• Lead or support design change projects including project scoping, impact assessment, implementation, and effectiveness verification.

• Develop, review, update, and maintain Design History File documentation and design input/output records.

• Lead or support risk management activities including Hazard Analyses, Use-Related Risk Analyses, Task Analyses, Design FMEAs, and benefit-risk assessments.

• Develop and execute Design Verification, Design Validation, Usability, and other qualification protocols and reports.

• Serve as a quality representative on project teams, providing guidance on quality system requirements, design controls, standards compliance, and regulatory expectations.

• Support investigations and resolution of complaints, nonconformances, CAPAs, product investigation reports, audit observations, field actions, and supplier quality issues.

• Apply structured problem-solving methodologies to identify root causes, assess risk, and implement effective corrective actions.

• Monitor post-market data, complaint trends, and product performance signals to assess risk and drive quality improvements.

• Support supplier qualification, audits, co-development activities, and ongoing supplier performance monitoring.

• Participate in internal, external, customer, and regulatory audits and inspection readiness activities.

• Drive continuous improvement initiatives focused on product quality, manufacturability, reliability, compliance, and cost effectiveness.

• Bachelor's degree in Engineering or related technical discipline.

• Minimum 5 years of experience in Design Assurance, Quality Engineering, Product Development, or a related role within a regulated industry.

• Knowledge of Design Controls, Risk…