[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Intuitive jobs](https://jobs.opennash.com/companies/intuitive/) · [Search jobs](/search/) Intuitive · Sunnyvale, CA # Senior (Quality Engineer 4) - Software/Firmware Sunnyvale, CA, United States Full-time Senior individual contributor Software Engineering Listed on Intuitive’s official careers site. Posted September 29, 2026. Check that it is still open and apply there. [Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000152457939-senior-quality-engineer-4-software-firmware) [OpenNash Jobs](https://jobs.opennash.com/) / [Intuitive](https://jobs.opennash.com/companies/intuitive/) / Senior (Quality Engineer 4) - Software/Firmware ## Job description Primary Function of Position The Senior Quality Engineer supports product development from concept through commercialization and serves as a core team member of the cross-functional software development team. This role provides expertise and guidance on software development lifecycle, design controls, risk management, anomaly tracking and code reviews. Additionally, the position ensures the compliance, reliability, and safety of software used in our medical devices. ### Essential Job Duties 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. ### Regulatory Support Support Regulatory Affairs with creating submissions and responding to submission questions. Support internal and external audits, including preparation and direct interaction with auditors. Process Improvement & Cross-Functional Collaboration Drive continuous improvement in software quality processes and methodologies. Work closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery. Implement test automation strategies to improve efficiency and coverage. ## Qualifications ### Required Skills and Experience 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 Required Education and Training Requires a minimum of 8 years of related experience with a University Degree (in computer science, software/biomedical/systems/electrical/mechanical engineering, math or physics) or 5 years of relevant experience and an Advanced Degree (in above disciplines) At least 2 years in a regulated industry is preferred Preferred Skills and Experience Preferred experience in AI/ML-based medical software (SaMD/embedded AI). Knowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA). ## At a glance - Posted by the employer: Sep 29, 2026 - First seen by OpenNash: Oct 13, 2026 - Last checked: Oct 20, 2026 - Listed for: 21 days - Location: Sunnyvale, CA, United States - Employment type: Full-time[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000152457939-senior-quality-engineer-4-software-firmware) ## More jobs at Intuitive ### [Embedded Software Engineer](https://jobs.opennash.com/companies/intuitive/jobs/816d7607a90621a138bc/) Sunnyvale, CA, United States ### [Equipment Engineering - Software](https://jobs.opennash.com/companies/intuitive/jobs/eeaf460bea4e0faeee68/) Sunnyvale, CA, United States ### [Full Stack Engineer](https://jobs.opennash.com/companies/intuitive/jobs/be8565ad80229ea176ab/) Sunnyvale, CA, United States ### [Future opportunities - Senior Embedded Software Engineer - Video Systems](https://jobs.opennash.com/companies/intuitive/jobs/0a522f8aa90651d773c1/) Sunnyvale, CA, United States ## Similar jobs at other companies ### [Staff Software/ Firmware Engineer](https://jobs.opennash.com/companies/infineon-technologies/jobs/86f7b2619030cb48cc2b/) Infineon Technologies · San Jose, CA ### [Senior Software Quality Engineer](https://jobs.opennash.com/companies/lockheed-martin/jobs/801193ac52acb8dcd868/) Lockheed Martin · Orlando, FL ### [Software Quality Engineer - E2](https://jobs.opennash.com/companies/lockheed-martin/jobs/3c323422ad774458e811/) Lockheed Martin · Huntsville, AL ### [Senior Software Engineer - Blade Server BMC Firmware Development](https://jobs.opennash.com/companies/microsoft/jobs/f4ae72ea3d09b451f436/) Microsoft · United States, Washington, Redmond, Texas, Houston, Oregon, Hillsboro, Austin, California, Mountain View ### [Software Design Quality Assurance Engineer](https://jobs.opennash.com/companies/bae-systems/jobs/d2cf6e6ec22680d723e1/) BAE Systems · Huntsville, Alabama, United States [Jobs in Sunnyvale, CA](/locations/us/ca/sunnyvale/)[Jobs in California](/locations/us-ca/)[Software Engineering jobs](/functions/software-engineering/) OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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