The Software Quality Assurance Engineer (Molecular Diagnostic Devices), under minimal supervision, supports software development activities including software requirements, architecture, design, implementation, documentation, integration, verification, and validation.
Key Responsibilities:

• Develop and execute unit, integration, software system V&V testing to ensure software functions within the application and with electrical and mechanical devices
• Develop and execute system level, functional and non-functional, integration, regression, performance/stability tests
• Create/Maintain traceability matrix – user needs, system requirements, software requirements, software architecture, and software design, test cases
• Create/Maintain test reports according to the V&V plan
• Verify and validate software requirements, software architecture, and software design; track and solve issues related to software and software-hardware integrations; release and maintain software; conduct software changes per regulations and controlled guidelines
• Participate in requirements review, design reviews, code reviews, test case reviews, and team meetings
• Help create/maintain software requirements, software architecture, software design specification documentation
• Create/Maintain and support the execution of SW verification/validation and/or code reviews as per project policy

 
Essential Skills & Experience:

• BS or MS in Electrical/Computer Engineering or Computer Science with a minimum of 3 years software quality/development experience
• Strong skills in C#/.Net framework, GUI and WPF framework, Python and XML, and/or similar high-level language
• Strong analytical and debugging skills in software and software-hardware integrations
• High accountability for teamwork assignments, concise and clear verbal, and written communication
• Passionate with a strong desire in developing business enabling new technologies
• Strong knowledge of software QA methodologies, tools, and processes. Experience writing clear, concise, and comprehensive test plans and test cases
• Medical device industry experience is a plus
• Experience with implementation of ISO 14971, 21 CFR 820, ISO 13485, IEC 62304 is a plus
• Experience with Quality/Design Assurance, and Design Control and Software Development initiatives for FDA Class II and Class III medical devices and software as a medical device is a plus
• Knowledge of Agile (Scrum) methodology is a plus

 
Skills and Experiences Preferred:

• Working experience in the medical device industry, ideally in complex IVD systems comprised of sensing for image acquisition, algorithms for image processing, or automated microfluidic control.
• Working experience in backend web service endpoint or IoT device management.
• Working experience in software test automation and DevOps CI/CD.
• Working experience in cross-platform integration and test for clinical automation applications.