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, 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 test/validation plans, protocols and results.
- Perform cybersecurity, risk and usability assessments.
- Track and triage defects.
- Provide guidance to development teams on application and interpretation of medical device standards and regulations.
- Be responsible for configuration and validation of SDLC, requirement and test management tools.
- Be responsible for maintenance and improvement of continuous integration and testing environments.
- Bachelor’s degree or higher in Computer Science, Electrical Engineering or equivalent field.
- 8+ years of experience in medical device software quality assurance.
- Excellent technical writing as well as verbal communication skills.
- Strong analytical skills and great attention to detail.
- Familiarity with FDA regulated software development life cycle processes, including Agile methods, and associated deliverables such as Requirements Specifications, Design Specifications, Verification/Validation Plans and Reports, and Risk Management documentation.
- Extensive knowledge of software and system testing and validation methods at all levels.
- Thorough understanding of ISO 14971, IEC 62304, IEC 60601, IEC 62366.
- Ability to understand use cases and application usage scenarios for planning and execution of software testing.
- Must be self-starter with the ability to coordinate work with other team members.
- Experience with SDLC tools for requirements management, configuration management, defect tracking and continuous integration.
- Fundamental technical understanding of basic PC hardware and wired/wireless networking technology and interfaces.
- Coaching and mentoring skills.
- Programming experience a plus.