SW Quality Assurance Engineer I

Boston Scientific•Santa Clarita, CA

6d•$62,800 - $119,300•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 Software Quality Assurance Engineer is responsible for providing critical Quality Engineering input across Neuromodulation Software and Firmware product development throughout the entire product lifecycle. This individual will contribute to both new product development and sustaining activities for commercialized products. Key areas of involvement include software and firmware development, testing, and validation to ensure compliance, reliability, and adherence to regulatory and quality standards. In the Neuromodulation division, we continue to advance science in electronic implantable technologies and capital equipment that help patients manage debilitating chronic pain and neurological conditions such as movement disorders. This is a full-time position based in Valencia, CA, with the expectation to be on-site three days per week. 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.

Requirements

Minimum of a BS degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or other related engineering discipline.
Minimum of 1 year’s experience.
Working knowledge of testing processes and methodologies.
Manual system-level testing experience in a regulated environment.
Some knowledge of mobile application development.
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, Software Engineering, or Electrical Engineering.
Excellent organizational, verbal, and written communication skills.
Team-oriented with strong interpersonal skills and a positive, can-do attitude when managing competing priorities across departments.
Detail-oriented with a passion for building quality into products.
Experience working in the medical device industry or other highly regulated environments.
Basic academic knowledge of principles of Neuromodulation.
Some experience with CAPA, complaint handling, and external audits.
Understanding of Risk Management per ISO 14971.
Familiarity with Premarket and Postmarket Cybersecurity Guidance and IEC 81001-5-1.
Understanding of Bluetooth technology.
Awareness of HIPAA and GDPR compliance practices.
ASQ Certified Quality Engineer (CQE) or ASQ Certified Software Quality Engineer (CSQE) certification.

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 test of software related to all Boston Scientific Neuromodulation product lines throughout the full development life cycle.
Support the creation and execution of Design Validation Plans, protocols, and reports, including system‑level testing, and 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 design, module-level design, code reviews, unit and integration testing, system-level testing (black box), structural testing (white box), test automation, ad hoc/exploratory testing, cybersecurity, usability, and risk management (including Design FMEAs and Hazard Analysis).