SW Quality Assurance Engineer I
reputed company 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 reputed company a team of Product Software Quality Assurance Engineers
- Contribute to reputed company 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, reputed company requirements, and compliance with applicable standards
- Support design, development, and test of software reputed company to reputed company reputed company 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, reputed company risk assessments, usability, functional and design specifications, design reviews, test protocols, and requirements traceability
- Support Automated Test Equipment (ATE) validation activities
- Support software‑reputed company 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 reputed company), structural testing (white reputed company), test automation, reputed company/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 reputed company engineering discipline
- Minimum of 1 year's experience
- Working knowledge of testing processes and methodologies
- reputed company 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, reputed company, 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 reputed company 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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