Principal Quality Systems Engineer - Global Risk Management & Design Activities

About the role

Boston Scientific was recognized by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work. Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

Responsibilities

• Serve as the global subject matter expert for Design Controls and Risk Management processes supporting combination products.
• Develop, implement and continuously improve global Design Activities and Risk Management procedures, methodologies and best practices that support compliant product development and lifecycle management.
• Partner with Global Quality System stewards, Design teams and cross-functional stakeholders to ensure effective governance, integration and continuous improvement of Global Design Activities and Risk Management processes.
• Collaborate with upstream and downstream process owners to maintain alignment between Design Activities and related Global Quality System processes, including Production and Process Controls, Material Controls and Post Market Surveillance.
• Analyze trends identified through Quality System audits, regulatory submissions, Quality Management Review (QMR) metrics and other performance indicators to identify compliance risks and opportunities for process improvement.
• Apply advanced analytical skills to synthesize qualitative and quantitative data, identify emerging trends and recommend sustainable solutions that strengthen process performance.
• Support Project Guardian initiatives by providing Design Controls and Risk Management expertise and implementing process enhancements that improve enterprise quality system performance.
• Lead Global Communities of Practice to promote collaboration, knowledge sharing, standardization and adoption of best practices across divisions.
• Support internal audits, external audits and regulatory inspections by providing documentation, audit responses and subject matter expertise.
• Lead Global Corrective and Preventive Action (CAPA) activities, including complex, cross-functional and multi-site investigations that drive sustainable quality system improvements.
• Apply advanced problem-solving methodologies and quality engineering principles to identify, prioritize and resolve complex quality issues while advancing continuous improvement initiatives and VIP objectives.

Requirements

• Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.
• Minimum of 7 years' experience in medical device Design Controls and Risk Management.
• Experience supporting the design, development and Risk Management of combination products.
• Demonstrated knowledge of Design Controls, Risk Management and product lifecycle quality processes for combination products.
• Working knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other applicable global medical device and combination product regulations.
• Proven experience leading cross-functional initiatives and influencing stakeholders within a global matrix organization.
• Strong analytical, problem-solving and decision-making skills.
• Demonstrated excellent written, verbal and presentation skills.

Preferred Qualifications

• Experience supporting pharmaceutical, biologic or drug-device combination product development throughout the product lifecycle.
• Strong project management skills with demonstrated success leading multiple cross-functional initiatives.
• Experience supporting internal audits, external audits or regulatory inspections.
• Experience leading Communities of Practice or enterprise governance initiatives.
• Proficiency with Microsoft 365 applications, including Excel, PowerPoint, Word and Teams.
• Experience applying Lean, Six Sigma or other continuous improvement methodologies to improve Global Quality System performance.