Clinical Software Quality Manager

Additional Location(s): US-MN-Maple Grove; US-MA-Marlborough

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: 

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 in Maple Grove, MN or Marlborough, MA 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. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Serve as a trusted advisor to clinical stakeholders (internal & external), providing clear, confident direction on software quality, governance, and risk. Ensure stakeholders leave software discussions aligned, reassured, and confident in the path forward.
• Bring strong software expertise with the ability to develop deep understanding of clinical systems and Real-World Data environments. Building on foundational knowledge of software systems and software validation growing an understanding of software & data through all phases of Clinical. 
• Communicate with executive presence and influence, building trust and alignment across cross-functional teams. Strong communication and interpersonal skills, capable of engaging cross-functional teams, resolving ambiguity, and influencing decisions as it related to software or data quality. 
• Lead the Clinical Software Quality team, including software auditors, driving accountability, high performance, and regulatory compliance. Manage the team that conducts periodic audits and qualification assessments for clinical, software, and pre-clinical vendors, verifying adherence to regulatory requirements (FDA, ISO 13485, IEC 60601, ISO 14155, 21 CFR Part 11, Computer Software Assurance) and Boston Scientific’s quality standards. 
• Drive continuous improvement and audit readiness, strengthening vendor oversight, risk-based controls, and quality system integration. 
• Lead, mentor, and develop the software auditing team, facilitating training programs and fostering a culture of collaboration and continuous improvement in audit and IT security practices. 
• Promote effective communication regarding types of clinical vendors, audit findings, and how vendor software affects clinical studies and research outcomes. 
• Support governance and corrective action management, ensuring that all issues are resolved in line with organizational and regulatory expectations.  

Required qualifications:

• Minimum Bachelor’s degree in computer science, engineering, life sciences, or a related field; advanced degrees preferred.
• Minimum of 5 years' experience in software quality, validation, audit, or quality systems within a regulated industry (e.g., medical devices, pharmaceuticals, life sciences).  
• Proven background in ISO 13485, IEC 60601, FDA guidelines, ISO 14155, and 21 CFR Part 11.
• Minimum of 3 years' experience in a managerial or leadership role within clinical, auditing, quality assurance, or regulatory compliance.
• Proven ability to lead, mentor, and develop teams, fostering collaboration and continuous improvement.

Preferred qualifications:

• Advanced experience in software quality, validation, or audit within a regulated environment (e.g., FDA, ISO 13485, GxP), with demonstrated understanding of risk-based approaches such as CSA and data integrity principles.
• Proven expertise in clinical systems, Real-World Data/Evidence, or Digital Health Technologies, including vendor oversight and governance of externally hosted platforms.
• Strong executive communication and stakeholder engagement skills, with experience influencing cross-functional teams and providing clear, defensible quality guidance at senior organizational levels. 

Requisition ID: 621977 

Minimum Salary: $ 82100 

Maximum Salary: $ 156000 

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.

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.