As part of our cross-functional development team, the Principal Software Quality Engineer is responsible for quality assurance of new product and software development for our Augmented Reality based surgical guidance systems, including planning and execution of software and hardware/system V&V activities. With a thorough understanding of the underlying software and hardware concepts, you will develop strategies for ensuring our products conform to regulatory and quality standards and help generate the documentation for regulatory filings.
Duties and Responsibilities:
- Support design, development, and testing of OnPoint’s products in conformance with FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, IEC 62304, and other applicable standards.
- Develop, write, and review product lifecycle deliverables, including product backlog, requirements specifications, sprint plans, risk analyses and traceability documentation.
- Develop and execute hardware and software test strategies and perform functional black box and white box, GUI, integration, system, and regression tests.
- Document formal verification/validation plans, protocols, and reports.
- Perform risk, cybersecurity, and usability assessments.
- Track and triage defects.
- Configure and validate software tools for product design, development, and testing.
- Maintain and improve continuous integration and testing environments.
- Provide guidance to development teams on application and interpretation of medical device standards and regulations.
- Provide guidance and mentorship to less experienced Quality personnel performing Design Verification and Validation activities or other quality functions.
- Bachelor’s degree or higher in Computer Science, Electrical Engineering, or equivalent field.
- 8+ years of experience in medical device software quality assurance.
- Thorough understanding and good working knowledge of 21 CFR 820, ISO 14971, IEC 62304, IEC 60601, IEC 62366.
- Extensive experience with FDA regulated software development life cycle processes, including Agile methods, and associated deliverables such as Requirements Specifications, Design Specifications, Verification/Validation Plans, Protocols, and Reports, and Risk Management documentation.
- Extensive knowledge of software and system verification and validation methods at all levels.
- Ability to understand use cases and apply use scenarios for planning and execution of software testing.
- Experience with SDLC tools for requirements management, configuration management, continuous integration, test management, and defect tracking.
- Fundamental technical understanding of basic PC hardware and wired/wireless networking technology and interfaces.
- Strong analytical skills and great attention to detail.
- Excellent technical writing as well as verbal communication skills.
- Must be a self-starter with the ability to coordinate work with other team members.
- Coaching and mentoring skills.
- Programming experience a plus.