Boston Scientific is a leading medical device company focused on advancing science for life. The Software Quality Assurance Engineer is responsible for providing critical Quality Engineering input across Neuromodulation Software and Firmware product development, ensuring compliance, reliability, and adherence to regulatory and quality standards throughout the product lifecycle.
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)
Qualification
Required
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
Preferred
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
