Sr. Global Software Quality Engineer

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

Develop, modify, apply, and maintain standards for software quality methods, processes, and procedures that meet Boston Scientific and external regulatory requirements. This role provides expertise in evaluating software systems and device validation activities, including requirements, design, AI risk assessment, security risk assessment, development, integration, testing, verification, deployment, and AI monitoring.

You will help establish methods for monitoring the compliance of software systems, cybersecurity, and AI processes, standards, and procedures. You will coach less experienced colleagues and collaborate on projects with cross-functional team members. This position spans IT, clinical, manufacturing, quality, quality systems, and device software validation and monitoring. Expertise in software validation in an Agile environment and knowledge of device software commercialization are essential.

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. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Act as an effective team member providing independent review and guidance on deliverables related to the development, implementation, and maintenance of device IT, clinical, manufacturing, quality, and quality system software.
• Demonstrate mastery of software validation processes and quality standards.
• Apply fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements.
• Collaborate with management to understand priorities and provide input on resource and time allocation.
• Provide full guidance on the acceptability of software quality and validation deliverables and lead the development and execution of validation strategies.
• Guide implementation of enterprise system solutions and device commercialization efforts through system planning, integration, and validation activities.
• Drive continuous improvement while ensuring defensibility of Boston Scientific software systems and device software to regulatory bodies.
• Contribute to the development, review, and/or approval of SOPs and supporting work instructions.
• Effectively communicate software verification and validation concepts across all levels of the organization.
• Champion the software quality process and lead or support departmental and cross-functional validation initiatives.
• Deliver structured quality assurance activities and metrics to support efficient, cost-effective operations.

Qualifications:

Required qualifications:

• Bachelor’s degree in science, engineering, or software discipline.
• Minimum of 6 years' experience in a related role, including at least 3 years' experience in software quality assurance and validation.
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, 21 CFR Part 11, IEC 62304, and cGxP for medical devices.
• Strong understanding of quality system requirements and their interdependencies.
• Experience with Agile software development and validation methodologies.
• Experience supporting enterprise system validations (e.g., SAP) and/or digital health/SaMD products.
• Some knowledge of cybersecurity and security risk analysis.
• Familiarity with work management and testing tools (e.g., JIRA, qTest).
• Comfortable communicating and presenting to leadership.
• Strong verbal and written communication skills.
• Creative and innovative problem-solving skills.
• Proven ability to manage projects and deliverables through to completion.
• Experience working independently and collaboratively in cross-functional teams.
• Strong organizational skills with the ability to manage multiple priorities.

Preferred qualifications:

• Experience or knowledge of design controls, risk management, and labeling processes.
• Experience or knowledge of GenAI applications.
• Understanding of risk management per ISO 14971 and AI risk assessments per the EU AI Act.
• Experience with AI implementation and monitoring plans.
• Familiarity with CAPA, vendor controls, complaint handling, and external audits.
• Basic understanding of HIPAA, GDPR, and data security regulations.
• Experience or knowledge of digital platforms and development tools such as Salesforce, GitLab, Bitbucket, and JIRA.

Requisition ID: 622844 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

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.