Job Description

Additional Location(s): N/A
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:
This is a high-impact opportunity for an experienced software-focused Principal Design Quality Engineer to provide strategic leadership and technical expertise supporting capital equipment and software product development within the Interventional Cardiology (IC) division. This position will lead software design quality efforts for high-visibility product development programs, ensuring compliance with global regulatory requirements and standards, while driving innovation and efficiency across the software development lifecycle (SDLC).
The Principal Software Design Quality Engineer serves as a leader in design controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory compliance for complex medical devices. In this role, you will partner with cross-functional leaders to influence product and process decisions, guide risk-based approaches, and mentor other engineers to elevate design quality capabilities across the organization.
Work mode:
At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN and requires being on-site at least three days per week.
Relocation assistance:
Relocation assistance is available for this position at this time.
Visa sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your responsibilities include:

• Serve as the primary software design quality lead for complex and strategic product development initiatives, from concept through commercialization.
• Drive and oversee implementation of risk management processes (ISO 14971), including hazard analysis, software FMEAs, and security risk analysis, ensuring integration into the development process.
• Lead development and execution of comprehensive software V&V strategies to ensure robust, compliance, and efficient testing aligned with IEC 62304 and other applicable standards.
• Provide expert guidance on system and software design controls, leading design reviews, software bug triage, and field issue investigations with a focus on systemic corrective actions.
• Champion the use of data-driven decision-making and advanced problem-solving methodologies to resolve quality issues and mitigate risks.
• Act as a regulatory and standards subject matter expert, contributing to regulatory strategy, authoring, and reviewing technical documentation for submissions, and representing software quality in audits and inspections.
• Develop and maintain software risk management tools (Hazard Analysis, FMEAs) with traceability to requirements, design, and test artifacts.
• Mentor and coach junior and senior engineers in software quality principles, risk management, and design controls.
• Collaborate with cybersecurity teams to ensure compliance with evolving security requirements and integrate security risk management into the product lifecycle.
• Partner with product development, systems engineering, and regulatory affairs to implement best practices and process improvements that enhance product safety and compliance.
• Foster a culture of quality and continuous improvement across cross-functional teams.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What we're looking for:
Required Qualifications

• Bachelor's degree in engineering, computer science, or related technical discipline and 9+ years of experience in design quality, software quality, or related medical device/regulated industry roles, with a focus on software-intensive products.
• Master's degree in engineering, computer science, or related technical discipline and 7+ years of experience in design quality, software quality, or related medical device/regulated industry roles, with a focus on software-intensive products.
• Proven expertise in Software Development Life Cycle (SDLC), risk management, and software verification and validation.
• Extensive experience with software quality tools, issue tracking (e.g., JIRA), and requirements/test management platforms.
• In-depth understanding of software configuration management, version control systems, and related quality controls.
• Demonstrated ability to lead cross-functional initiatives, influence without direct authority, and make strategic quality decisions.
• Exceptional verbal and written communication skills, with experience presenting to leadership and external regulatory bodies.
• Strong analytical and problem-solving skills, with a record of resolving complex quality issues.
• Ability to travel up to 25%

Preferred Qualifications

• Comprehensive knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and related software standards.
• Experience with global regulatory submissions and interacting with notified bodies or FDA.
• Background in embedded software, systems engineering, or integration of hardware and software systems.
• Experience in code review practices and secure coding principles.
• Advanced degree in engineering, computer science, or related field.

Requisition ID: 619739
Minimum Salary: $ 99100
Maximum Salary: $ 188300
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.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
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.

Skills Required