Principal Quality Systems Engineer - Capital Equipment

Work mode: Hybrid

Onsite Location(s):

Arden Hills, MN, US, 55112

Additional Location(s): US-MN-Arden Hills

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.

The Principal Quality Engineer - Capital Equipment Systems represents the capital equipment quality function within Project Magellan, Boston Scientific’s global transformation program deploying SAP S/4HANA and the global service management system.

This role partners with business process owners, IT, quality, and commercial operations teams to define quality and business process requirements and translate them into scalable system solutions. The position ensures that systems are designed, implemented, and function as intended to support compliant, efficient, and traceable capital equipment operations across the commercial lifecycle, including service, repair, distribution, and redeployment. In addition, this role supports global rollout activities, including change management, training, and communication, while driving consistency and alignment of quality processes and standards across regions and functions.

As a principal-level individual contributor, this position provides strategic leadership and subject matter expertise at the intersection of quality, digital systems, and global commercial operations, shaping how capital equipment requirements are embedded into enterprise platforms and driving alignment across regions and functions.

Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

● Strategic quality leadership: Serve as the global quality subject matter expert for capital equipment within Project Magellan across service, repair, distribution, and redeployment. Define and drive the strategy for embedding capital equipment quality and regulatory requirements into business processes and system capabilities. Influence cross-functional decisions to ensure solutions support compliant, scalable, and future-state operations.

● Business process design and requirements leadership: Lead collaboration with global capital equipment business process teams, IT, and subject matter experts to define end-to-end processes aligned with SAP S/4HANA and global service management systems. Translate complex quality system requirements into business process and system requirements. Ensure processes are designed to deliver compliant outcomes with appropriate controls, traceability, and data integrity.

● Operational domain leadership: Provide leadership across key domains, including service and repair operations, distribution and logistics, import and export requirements, and redeployment of capital equipment.

● Solution design influence and risk management: Provide expert review and guidance on system and process designs to ensure alignment with capital equipment quality and regulatory expectations. Identify and drive resolution of cross-functional risks, gaps, and compliance considerations. Shape decisions that balance compliance, operational efficiency, and system scalability.

● User acceptance testing and business validation: Lead capital equipment quality input into user acceptance testing strategy and execution. Define quality-critical business scenarios, use cases, and acceptance criteria reflective of global operations. Ensure solutions are validated as fit for purpose to support compliant commercial lifecycle processes.

● Change management, training, and deployment readiness: Provide leadership in organizational change management to support adoption of new processes and systems. Oversee development and alignment of procedures, work instructions, training strategies, and business readiness activities. Ensure capital equipment quality considerations are embedded in global rollout and adoption plans.

● Quality system integration and continuous improvement: Drive alignment between future-state processes and the Boston Scientific quality system. Lead updates and enhancements to quality system processes, controls, and documentation impacted by Project Magellan. Champion opportunities to improve compliance, efficiency, and user experience through digital enablement.

● Global stakeholder influence and alignment: Influence and align senior stakeholders across quality, IT, commercial, and operations functions. Act as a key bridge between technical and business teams, ensuring clarity of quality requirements and priorities. Provide clear communication on risks, decisions, and readiness to program leadership.

Required qualifications:

● Bachelor’s degree in engineering, science, or a related field.

● Minimum of 7 years' experience in quality, engineering, operations, software quality assurance, or related roles.

● Minimum of 3 years' experience in the medical device or regulated industry.

● Experience with business process design and requirements definition.

● Knowledge of quality systems and global regulatory expectations.

Preferred qualifications:

● Experience leading business process design and requirements definition in large-scale system transformations.

● Experience with SAP S/4HANA, global service management systems, or similar enterprise platforms.

● Deep understanding of commercial lifecycle operations, including service, repair, distribution, and logistics.

● Experience with capital equipment and associated regulatory considerations.

● Familiarity with user acceptance testing and business validation methodologies.

● Experience in organizational change management, training, and global deployments.

● Knowledge of FDA, EU MDR, and international regulatory frameworks.

● Demonstrated ability to influence at senior levels and operate effectively in a global matrix organization.

Requisition ID: 628584

Minimum Salary: $ 102100

Maximum Salary: $ 194000

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.

Nearest Major Market: Minneapolis
Job Segment: Testing, Embedded, Compliance, Medical Device Engineer, Quality Engineer, Technology, Legal, Engineering

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