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 (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.

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.

Nice To Haves

• 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.

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.

Benefits

• The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role.
• Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.
• At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Principal