Global Design Controls Lead - Quality Systems

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) 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.

Required qualifications:

• 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.

Preferred qualifications:

• 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.

Requisition ID: 631073 Minimum Salary: $ 89200 Maximum Salary: $ 169500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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 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. #J-18808-Ljbffr B Capital