Principal Quality Systems Engineer - Global Risk Management & Design Activities

Principal Quality Systems Engineer
- Global Risk Management & Design Activities

Work mode:
Hybrid Onsite Location(s):
Marlborough, MA, US, 01752 Additional Location(s): US-MA-Marlborough; US-IN-Spencer; US-MN-Arden Hills; US-MN-Maple Grove 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.

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. We are seeking a Principal Quality Systems Engineer – Global Risk Management & Design Activities (Combination Products) to join the Global Quality Systems organization.

In this enterprise leadership role, you will serve as the global subject matter expert for Design Controls and Risk Management processes supporting combination products. You will lead strategic initiatives that strengthen the Global Quality System, support Project Guardian and other enterprise transformation initiatives, and ensure compliance with Boston Scientific quality standards and global regulatory requirements. This role will be working closely with Global Quality System stewards, Design teams and cross-functional stakeholders, you will develop, govern and continuously improve global processes that support the design, development and lifecycle management of combination products.

This role will also lead Global Communities of Practice (CoPs), promote process harmonization and drive best practices that enhance product quality, patient safety and regulatory compliance across the enterprise.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota;
Marlborough, Massachusetts; or Spencer, Indiana. 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.

Your responsibilities will include:

• 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.
• S…