Senior SW Quality Assurance Engineer
Valencia, CA, US, 91355
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:
Boston Scientific ranked #2 among medical device companies on Forbes America's Best Places to Work for Engineers 2026. Whether your passion lies in systems, software, human factors, or beyond, this is a place where you can grow your career and be part of something bigger—advancing science for life.
The Senior Software Quality Assurance Engineer serves as a key Quality representative within Neuromodulation Software and Firmware product development. This role provides critical Quality Engineering input throughout the entire product life cycle.
You will actively participate in the design and development of new products and support sustaining activities for commercialized products. This includes involvement in software and firmware development, testing, and validation to ensure compliance, reliability, and adherence to regulatory and quality standards.
This is a 2-year defined term contract position based in our Neuromodulation division, where we continue to advance science in electronic implantable technologies that help patients manage debilitating chronic pain and neurological conditions such as movement disorders.
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:
- Work collaboratively within a team of Product Software Quality Assurance Engineers.
- Contribute to all aspects of software and firmware quality assurance in a highly regulated active implantable and capital equipment medical device environment.
- Ensure the quality of software systems by validating software and firmware requirements, security requirements, and compliance with applicable standards.
- Support design, development, and testing of software related to all Boston Scientific Neuromodulation product lines throughout the entire development life cycle, from requirements gathering through retirement.
- Support the creation and execution of design validation plans, protocols, and reports, including system‑level testing. Document and escalate any issues identified.
- Review software and firmware design, development, and testing activities to ensure adherence to quality and regulatory expectations.
- Review and approve documentation including user requirements, hazard analysis, security risk assessments, usability, functional and design specifications, design reviews, test protocols, and requirements traceability.
- Support Automated Test Equipment (ATE) validation activities.
- Support software‑related CAPA (Corrective and Preventive Actions) activities.
- Support design validation activities, including review of user needs requirements, design requirements, functional and architectural specs, module design, code and design reviews, unit and integration tests, system-level testing (black box), structural testing (white box), test automation, ad-hoc/exploratory testing, cybersecurity, usability, risk management, design FMEAs, and hazard analysis.
Qualifications:
Required qualifications:
- Minimum BS degree in Computer Science, Software Engineering, Electrical E
- ngineering, Biomedical Engineering, or other relevant engineering disciplines
- Minimum of 5 years' experience in software quality assurance or related rolesWorking knowledge of testing processes and methodologies
- Manual system-level testing experience in a regulated environment
- Understanding of Software Development Life Cycle (SDLC) processes per IEC 62304
- Some experience in programming languages such as C#, C++, Swift, Node.js, Java/JavaScript, Cloud, Windows, iOS, Android, Python, or LabView
Preferred qualifications:
- MS degree in Computer Science or Software/Electrical Engineering
- Excellent organizational, verbal, and written communication skills
- Team-oriented mindset with strong interpersonal skills and a positive, proactive attitude
- Detail-oriented with a passion for building quality into products
- Experience working in the medical device industry or other highly regulated environment
- Basic academic knowledge of principles of Neuromodulation
- Some experience with CAPA, complaint handling, and external audits
- Experience or understanding of risk management per ISO 14971
- Familiarity with premarket and postmarket cybersecurity guidance and IEC 81001-5-1
- Understanding of Bluetooth technology
- Experience with mobile application development
- Awareness of HIPAA and GDPR compliance practices
- ASQ Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE)
Requisition ID: 622637
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 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.
Nearest Major Market: Los Angeles
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Biomedical Engineering, Testing, Test Engineer, Quality Engineer, Senior Quality Engineer, Engineering, Technology