SW Quality Assurance Engineer I

Boston Scientific is a leader in medical science dedicated to advancing science for life. The Software Quality Assurance Engineer I will provide critical Quality Engineering input across Neuromodulation Software and Firmware product development, ensuring compliance and quality throughout the product lifecycle.

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)

Skills

• 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
• 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

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