Principal Quality Systems Engineer - Global Risk Management & Design Activities

bostonscientific•Maple Grove, MA

8d•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 Principal Quality Systems Engineer – Global Risk Management & Design Activities to join the Global Quality Systems organization. In this enterprise leadership role, you will serve as a global subject matter expert for Design Controls and Risk Management processes, with a focus on capital equipment and complex systems. You will lead strategic initiatives that strengthen the Global Quality System, support Project Guardian and other enterprise transformation efforts, and ensure compliance with Boston Scientific quality standards and global regulatory requirements. The incumbent will be working closely with Global Quality System stewards, Design teams and cross-functional stakeholders, you will establish and govern global processes, drive standardization and continuous improvement, and lead Global Communities of Practice (CoPs) that advance risk management excellence across the product lifecycle. This role offers the opportunity to influence quality strategy, improve product development processes and strengthen patient safety through enterprise-wide collaboration.

Requirements

Minimum Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.
Minimum of 7 years' experience in medical device Design Controls, Risk Management or Global Quality Systems.
Demonstrated expertise in Design Controls, Risk Management and product lifecycle quality processes for complex medical devices and capital equipment.
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 regulations.
Proven experience leading enterprise-level quality initiatives and influencing cross-functional stakeholders within a global matrix organization.
Demonstrated experience leading complex, multi-site CAPAs and enterprise process improvement initiatives.
Demonstrated strong analytical, problem-solving and strategic decision-making skills.

Nice To Haves

Experience supporting capital equipment or complex electromechanical medical device development.
Excellent written, verbal and presentation skills with demonstrated ability to communicate effectively across all organizational levels.
Advanced project management skills with experience leading large-scale, cross-functional initiatives and managing multiple priorities.
Demonstrated experience leading Communities of Practice, governance teams or enterprise quality councils.
Advanced proficiency with Microsoft 365 applications, including Teams, Excel, PowerPoint and Word.
Proven experience applying Lean, Six Sigma or other continuous improvement methodologies to improve Global Quality System performance.
Proven experience supporting internal audits, external audits and regulatory inspections.

Responsibilities

Serve as the global subject matter expert for Design Controls and Risk Management processes, with an emphasis on capital equipment and complex systems.
Develop, govern and continuously improve Global 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 consistent implementation and continuous improvement of Global Risk Management and Design Activities processes.
Lead Global Communities of Practice to promote collaboration, knowledge sharing, process harmonization and adoption of enterprise best practices.
Analyze trends identified through Quality System audits, regulatory submissions, Quality Management Review (QMR) metrics and other performance indicators to identify opportunities for process improvements and enhanced compliance.
Partner with upstream and downstream process owners to maintain effective integration between Global Risk Management, Design Activities and related Global Quality System processes, including Production and Process Controls, Material Controls and Post Market Surveillance.
Support Project Guardian initiatives by providing technical leadership, process expertise and implementation support for Design Controls and Risk Management activities.
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 system issues.
Drive enterprise continuous improvement initiatives that simplify business processes, improve operational effectiveness and support VIP objectives.