Boston Scientific · 2 hours ago
Senior SW Quality Assurance Engineer
Valencia, CA
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $170K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving the most important health industry challenges. The Senior Software Quality Assurance Engineer serves as a key Quality representative within Neuromodulation Software and Firmware product development, providing critical Quality Engineering input throughout the entire product life cycle.
Health CareMedicalMedical Device
No H1B
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
Qualification
Required
Minimum BS degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or other relevant engineering disciplines
Minimum of 5 years' experience in software quality assurance or related roles
Working 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
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)
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
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