Principal Quality Systems Engineer - Global Risk Management & Design Activities

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 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.

● 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.

Required qualifications:

● 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.

Preferred qualifications:

● 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.

Requisition ID: 631119 

Minimum Salary: $ 106800 

Maximum Salary: $ 202900 

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).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.