Senior SW Quality Assurance Engineer

Boston Scientific•Santa Clarita, CA

3d•$89,200 - $169,500•Hybrid

About The Position

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.

Requirements

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

Nice To Haves

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)

Responsibilities

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.