{"id":1495837,"url":"https://alion.io/job/intuitive-surgical-senior-quality-engineer-4-softwarefirmware","title":"Senior (Quality Engineer 4) - Software/Firmware","company":{"id":3128,"name":"Intuitive Surgical","domain":"intuitive.com","url":"https://alion.io/company/intuitive","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":75,"open_postings":61,"ghost_share":0,"stale_share":0.984,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-10-12T06:55:09Z"}},"role":"QA","role_family":"QA","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sunnyvale, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":100000,"max_usd":200000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":493},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"GDPR","optional":true},{"name":"HIPAA","optional":true},{"name":"ISO 27001","optional":true}],"status":"live","first_seen_at":"2026-09-29T14:24:52Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-12T23:48:43Z","board_verified":true,"closed_at":null,"days_open":13,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":13},"description":"It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion -have transformed how care is delivered for millions of patients worldwide.\nWe’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.\nThe problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.\nIf you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.\n Primary Function of Position\nThe 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.\nEssential Job Duties\nSoftware Quality Assurance & Compliance\nDevelop, implement, and maintain software quality processes in compliance with ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, and MDR.\n\nParticipate in design reviews, code reviews, defect tracking and reviews, and software validation activities.\n\nEnsure adherence to software development lifecycle (SDLC) processes, including Agile methodologies.\n\nRisk Management\nSupport risk management activities in accordance with ISO 14971, IEC 62304, and ISO 80002-1\n\nCollaborate with R&D and testing teams to identify and mitigate software defects.\n\nEnsure the completeness and full coverage of software verification and validation (V&V) protocols, including unit testing, integration testing, and system testing.\n\nDesign Control\nParticipate in and support the development of the product design history file, ensuring compliance with internal processes and external standards and regulations.\n\nPartner with engineering to define design inputs, design outputs, and traceability matrices.\n\nRegulatory Support:\nSupport Regulatory Affairs with creating submissions and responding to submission questions.\n\nSupport internal and external audits, including preparation and direct interaction with auditors.\n\nProcess Improvement & Cross-Functional Collaboration\nDrive continuous improvement in software quality processes and methodologies.\n\nWork closely with software development, regulatory affairs, manufacturing, and post-market teams to ensure high-quality software delivery.\n\nImplement test automation strategies to improve efficiency and coverage.\n\n Required Skills and Experience\nExperience in medical device standards such as IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, and FDA Design Controls.\n\nExperience with risk-based software validation, software test automation, and SDLC processes\n\nExpertise with data modeling and interpretation in areas like field product performance, log analysis, reliability modeling.\n\nAbility to navigate quality systems with minimal oversight on individual projects.\n\nBalanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.\n\nAbility to solve complex problems with minimal oversight.\n\nAbility to articulate complex information to teams, including executive management\n\nRequired Education and Training\nRequires 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)\nAt least 2 years in a regulated industry is preferred\nPreferred Skills and Experience\nPreferred experience in AI/ML-based medical software (SaMD/embedded AI).\n\nKnowledge of cybersecurity and data privacy (IEC 81001-5-1, ISO 27001, NIST, GDPR, HIPAA).\n\n Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.\nIntuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.\nMandatory Notices\nU.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.\nCertain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).\nFor any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.\nWe will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.\nPreference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.\nThis position may be filled at a different job level than listed here depending on\nbusiness need and/or on the selected candidate’s experience, knowledge and skills.\nCompensation will be based primarily on the job level at which the role is filled and the\ncandidate’s qualifications, consistent with applicable law.\nAccommodation & Accessibility Notice:\nIntuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at .\nWe provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. 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