Senior Quality Systems Engineer - Global Design Controls

Senior Quality Systems Engineer
- Global Design Controls

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. Here, you'll be supported in progressing – whatever your ambitions.

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 Senior Quality Systems Engineer – Global Design Controls to join the Global Quality Systems organization.

In this role, you will serve as a Global Design Activities Process Owner, leading the governance, development and continuous improvement of enterprise Design Activities processes that support the design, development and lifecycle management of medical devices. The incumbent will be working across divisions and functions, you will partner with Design teams, Global Design Activities sub-process stewards and cross-functional stakeholders to establish standardized processes, strengthen quality system performance and ensure compliance with global regulatory requirements.

This role will also lead Global Communities of Practice (CoPs), drive process harmonization and support strategic initiatives that advance product quality, innovation and operational excellence 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 Design Activities Process Owner, driving governance, process effectiveness and continuous improvement across enterprise Design Activities sub-processes. Develop, implement and maintain global Design Activities procedures, methodologies and best practices that support compliant product development and lifecycle management. Partner with upstream and downstream process owners to ensure effective integration 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 opportunities for process optimization and compliance improvements. Apply advanced analytical skills to evaluate qualitative and quantitative data, identify key trends and provide actionable recommendations that strengthen process performance. Support Project Guardian initiatives by assessing Design Activities impacts and implementing sustainable process improvements.

Lead Global Communities of Practice to promote collaboration, knowledge sharing, standardization and adoption of best practices across divisions. Influence cross-functional stakeholders and subject matter experts to drive alignment, resolve complex quality issues and improve enterprise Design Activities processes. Support internal audits, external audits and regulatory inspections by providing documentation, audit responses and subject matter expertise. Lead Global Corrective and Preventive Action (CAPA)…