Design Quality Engineer II

Additional Location(s): US-MA-Marlborough

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 advance your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Boston Scientific ranked #2 among medical device companies on Forbes America’s Best Places to Work for Engineers 2026. Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger—advancing science for life.

This role provides technical expertise and data analysis to support Boston Scientific’s Urology division in post‑market surveillance, with a primary focus on Periodic Safety Updates under EU MDR. You’ll analyze product performance and complaint data to detect trends and potential safety signals, supporting product sustainment and escalation decisions. The position communicates findings, educates cross‑functional teams – and occasionally external customers – on product performance and trending, while leading or coordinating projects aligned with business, departmental, and global BSC priorities.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Marlborough, MA office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Analyze customer complaints, compliance events, clinical data, and other post‑market surveillance data by examining patterns and trends, and investigating as needed.
• Investigate potential and/or identified trends or data issues in collaboration with cross‑functional teams.
• Manage potential actions by updating Post Market reports at appropriate intervals, including conducting Health Risk Analyses and Risk Management reviews when necessary.
• Document data reviews, trend analysis, escalations, and actions in formal regulatory submission reports (e.g., PSUR) for Notified Body review.
• Communicate product performance through presentations to management, cross‑functional teams, committees, and design teams, supporting published product performance reports.
• Drive continuous improvement by leading projects within local and global Design Assurance and Post Market teams to enhance process and product performance.
• Foster a diverse and inclusive workplace that empowers all individuals to contribute to their full potential.
• Maintain compliance with the Quality Policy and documented processes to uphold patient safety and product quality.
• Support process improvement initiatives and help develop tactical plans aligned with team strategies.

• Minimum of 2 years’ experience within the medical device industry.
• Bachelor’s degree in Engineering or a scientific discipline.
• Demonstrated problem‑solving and critical‑thinking skills.
• Experience working in regulated environments with clinical teams; ability to interpret and analyze clinical data and terminology.
• Advanced knowledge of Microsoft Excel.
• Proficient with Microsoft Office tools including Word, PowerPoint, Teams, and Outlook.

• Strong communication and presentation skills; comfortable speaking to groups and clearly translating complex performance data to peers and senior leaders.
• Strong collaboration skills with the ability to influence across cross‑functional teams.
• Proven ability to manage multiple tasks and adapt to shifting priorities.
• Knowledge of analytical techniques, problem‑solving, continuous improvement programs, data analytics, and statistical analysis.
• Demonstrated statistical and data analysis capabilities.
• Self‑starter mindset with a drive to identify and act…