Senior Quality Systems Engineer - Global Design Controls

Boston Scientific•Arden Hills, MN

7d•$89,200 - $169,500•Hybrid

About The Position

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.

Requirements

Minimum Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.
Minimum of 5 years' experience in medical device Design Controls and Risk Management.
Demonstrated experience of Design Controls, Design Activities and product lifecycle quality processes.
Proven knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR and other applicable global medical device regulations.
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.

Nice To Haves

Experience supporting combination products within a regulated medical device or pharmaceutical environment.
Experience supporting internal audits, external audits or regulatory inspections.
Strong project management skills with demonstrated success leading multiple cross-functional initiatives.
Experience facilitating cross-functional collaboration and Communities of Practice.
Proficiency with Microsoft 365 applications, including Excel, PowerPoint, Word and Teams.
Proven experience applying Lean, Six Sigma or other continuous improvement methodologies to improve quality system performance.

Responsibilities

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) activities, including complex, cross-functional and multi-site investigations that improve process effectiveness and regulatory compliance.
Apply structured problem-solving methodologies to identify, prioritize and resolve quality system issues while supporting VIP and enterprise continuous improvement objectives.