{"id":1495840,"url":"https://alion.io/job/intuitive-surgical-senior-software-quality-engineer-4-coe-structure","title":"Senior Software (Quality Engineer 4) - CoE structure","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":102000,"max_usd":203000,"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":"Azure DevOps","optional":false},{"name":"C#","optional":false},{"name":"C++","optional":false},{"name":"CAPA","optional":false},{"name":"CI/CD","optional":false},{"name":"Configuration Management","optional":false},{"name":"Git","optional":false},{"name":"GitHub Actions","optional":false},{"name":"GitLab CI","optional":false},{"name":"JavaScript","optional":false},{"name":"Jenkins","optional":false},{"name":"Python","optional":false},{"name":"SBOM","optional":false},{"name":"Shift-Left","optional":false},{"name":"Shift-Left Security","optional":false},{"name":"Threat Modeling","optional":false},{"name":"Azure","optional":true}],"status":"live","first_seen_at":"2026-09-29T14:15:55Z","employer_posted_date":"2026-10-01","last_verified_at":"2026-10-13T03:06:15Z","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 Software Quality Engineer serves as a technical quality leader providing independent quality oversight for Software as a Medical Device (SaMD), Software in Medical Device (SiMD), Digital Health, AI/ML-enabled products, and cloud-connected healthcare solutions. This role partners closely with Software Engineering, Systems Engineering, Product Security, Regulatory Affairs, and Product Quality teams to drive quality by design throughout the software development lifecycle.\nUnlike traditional quality roles focused primarily on documentation review and compliance activities, this position engages early in product development to identify technical risks, influence software quality practices, evaluate architecture decisions, promote testability, and strengthen software delivery processes while maintaining independent quality judgment.\nThe Senior Software Quality Engineer participates in requirements, architecture, design, verification, cybersecurity, and release readiness reviews as a technical quality partner. The role is responsible for ensuring software products are developed using sound engineering practices and comply with applicable regulatory, quality, cybersecurity, and risk management expectations.\nThis individual is expected to possess strong software engineering knowledge, a deep understanding of modern SDLC practices, and the ability to effectively challenge technical decisions through objective quality and risk-based assessment.\nThe Senior Software Quality Engineer serves as a technical quality partner and independent quality authority. The role actively participates in requirements, architecture, and design activities; however, ownership of engineering requirements, software architecture, implementation decisions, and design specifications remains with Engineering. The SW QE provides technical quality consultation, risk assessment, and independent oversight while maintaining objectivity for design control and release decisions.\nEssential Job Duties:\nTechnical Quality Leadership\nServe as the Product Quality representative for software-intensive products and provide independent quality oversight across the software development lifecycle.\nPartner with software and systems engineering teams to drive quality-by-design principles early in product development.\nParticipate in architecture, design, and technical review activities to identify quality, reliability, maintainability, and cybersecurity risks before implementation.\nEvaluate software development practices and ensure alignment with industry-recognized engineering and quality principles.\nPromote shift-left quality practices that prevent defects rather than relying solely on downstream verification activities.\nSoftware Development Lifecycle Oversight\nAssess software lifecycle execution against IEC 62304, FDA Quality System requirements, ISO 13485, and applicable organizational procedures.\nReview software requirements, design specifications, risk controls, traceability structures, verification strategies, and release evidence to ensure lifecycle integrity.\nProvide quality consultation on software development methodologies including Agile, DevOps, CI/CD, iterative development, and hybrid lifecycle models.\nEvaluate software engineering deliverables for quality, completeness, maintainability, testability, and technical risk.\nArchitecture & Design Quality\nParticipate in software architecture and design reviews as an independent quality and risk management partner.\nAssess system designs for scalability, modularity, reliability, resilience, maintainability, and testability.\nReview integration architectures, interface designs, cloud-connected systems, APIs, embedded systems, and software platforms for quality and compliance concerns.\nChallenge technical assumptions and facilitate risk-based discussions regarding design decisions and implementation approaches.\nDevOps, Configuration Management & Release Quality\nEvaluate software configuration management practices including source control, branching strategies, build management, release management, and product traceability.\nAssess CI/CD pipelines and automated quality gates for effectiveness and regulatory compliance.\nReview software release readiness criteria, build reproducibility controls, deployment processes, and software integrity safeguards.\nProvide oversight of software bill of materials (SBOM), software configuration baselines, and release governance activities.\nVerification, Validation & Test Engineering\nAssess software verification and validation strategies using risk-based and quality-focused approaches.\nEvaluate automation frameworks, test coverage, traceability, defect trends, and verification effectiveness.\nPromote development of automated testing solutions including unit, integration, system, API, performance, and end-to-end testing approaches.\nDrive testability considerations during requirements and architecture phases.\nCybersecurity & Secure Development\nEvaluate software cybersecurity risks throughout the product lifecycle.\nCollaborate with Product Security and Cybersecurity teams to promote Secure SDLC practices.\nParticipate in threat modeling, security risk assessments, vulnerability reviews, and cybersecurity readiness activities.\nSupport compliance with FDA cybersecurity guidance, NIST frameworks, and industry best practices for secure medical device development.\nAI/ML & Digital Health Quality\nSupport quality and regulatory oversight of AI/ML-enabled software solutions.\nAssess AI lifecycle controls related to data quality, model validation, bias mitigation, transparency, and traceability.\nPromote risk-based validation strategies for AI-enabled healthcare products.\nSupport adoption of emerging technologies while maintaining patient safety, product quality, and regulatory compliance.\nQuality Systems & Continuous Improvement\nSupport development and continuous improvement of software quality processes and procedures.\nParticipate in CAPA investigations, root cause analysis, audits, inspections, and continuous improvement initiatives.\nDevelop and monitor software quality metrics that support risk-based decision making.\nProvide technical mentorship and guidance to engineering teams on software quality best practices.\n Required Skills and Experience\nEducation\nBachelor's or Master's degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or a related technical discipline.\nSoftware Engineering Experience\nMinimum 8 years of experience in software engineering, software quality engineering, software test engineering, systems engineering, or related software development disciplines.\nAssess software lifecycle execution against IEC 62304, FDA Quality System requirements, ISO 13485, and applicable organizational procedures.\nPrior hands-on experience in software development, software testing, automation engineering, DevOps, systems engineering, or product development environments.\nDemonstrated ability to understand and evaluate software implementations beyond document review activities.\nTechnical Competencies\nStrong understanding of the complete Software Development Life Cycle (SDLC) including requirements, architecture, design, implementation, verification, deployment, maintenance, and post-market support.\nWorking knowledge of software programming concepts and software development practices.\nAbility to review and understand software code, architecture diagrams, interface designs, and technical implementation approaches.\nDemonstrated ability to read, understand, and evaluate production software implementations, software architecture, and technical design decisions.\nAbility to review source code, pull requests, automation frameworks, and CI/CD workflows to identify quality, reliability, maintainability, and compliance risks.\nExperience working with software technologies such as C++, Python, C#, Java, JavaScript, or similar languages sufficient to assess implementation quality and technical risk.\nThe successful candidate can credibly engage with software engineers, understand software architecture and implementation decisions, review code and technical artifacts, identify technical quality risks, and independently influence software quality outcomes throughout the development lifecycle.\nDevOps & Configuration Management\nExperience with Git-based source control systems.\nUnderstanding of modern software configuration management principles.\nExperience with CI/CD technologies including Azure DevOps, Jenkins, GitHub Actions, GitLab CI/CD, or equivalent platforms.\nKnowledge of software build systems, deployment pipelines, release management, and software traceability controls.\nTest Automation & Quality Engineering\nExperience evaluating or developing automated testing solutions.\nKnowledge of software testing methodologies including unit testing, integration testing, system testing, and performance testing.\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, Pennsylv...","description_format":"text","description_chars":13004,"description_truncated":true,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Equity"],"hiring_locations":[{"name":"United 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