Senior Quality Engineer - Software/Firmware

Job description

Job responsibilities

• Software Quality Assurance & Compliance Develop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.
• Participate in design reviews, code reviews, defect tracking and reviews, and software validation activities.
• Ensure adherence to software development lifecycle (SDLC) processes, including Agile methodologies.
• Risk Management Support risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1
• Collaborate with R&D and testing teams to identify and mitigate software defects.
• Ensure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.
• Design Control Participate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.
• Partner with engineering to define design inputs, design outputs, and traceability matrices.

Job requirements

• Experience in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.
• Experience with risk-based software validation, software test automation, and SDLC processes
• Expertise with data modeling and interpretation in areas like field product performance, log analysis, reliability modeling.
• Ability to navigate quality systems with minimal oversight on individual projects.
• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
• Ability to solve complex problems with minimal oversight.
• Ability to articulate complex information to teams, including executive management
• Preferred experience in AI/ML-based medical software (SaMD/embedded AI).