SW Quality Assurance Engineer I

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, and document and escalate any issues identified. 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). 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.