Senior SW Quality Assurance Engineer

Boston Scientific • Santa Clarita, CA

8d

About The Position

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 the creation and execution of design validation plans, protocols, and reports, including system‑level testing. 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.

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 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
• 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 the creation and execution of design validation plans, protocols, and reports, including system‑level testing.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees