Boston Scientific is looking for a Senior Software Quality Assurance Engineer for a 2-year defined term contract based in our Neuromodulation division, which focuses on electronic implantable technologies for chronic pain and neurological conditions. You will serve as a key Quality representative within Software and Firmware product development, providing critical input throughout the entire product life cycle.
What You'll Do
- 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.
What We're Looking For
- 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.
Nice to Have
- 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.
Technical Stack
- C#
- C++
- Swift
- Node.js
- Java/JavaScript
- Cloud
- Windows
- iOS
- Android
- Python
- LabView
Team & Environment
You will work within a team of Product Software Quality Assurance Engineers.
Work Mode
This is a hybrid position with work split between a local office and remote.
Boston Scientific embraces diversity, innovation, caring, global collaboration, a winning spirit, and high performance.
