3 days ago
Base Salary
$128k - $216k/yr
Responsibilities
- Develop, implement, and maintain software quality processes for medical-device software in compliance with applicable standards and regulations.
- Participate in design reviews, code reviews, defect tracking, software validation, and software development lifecycle activities.
- Support software risk management, defect identification and mitigation, and verification and validation coverage for unit, integration, and system testing.
- Support design controls, design history files, design inputs and outputs, and traceability matrices.
- Assist Regulatory Affairs with submissions, submission questions, and internal and external audits.
- Drive continuous improvement in software quality processes and implement test automation strategies.
- Collaborate with software development, regulatory affairs, manufacturing, post-market, R&D, and testing teams.
Requirements
- Minimum of 8 years of related experience with a university degree in computer science, software, biomedical, systems, electrical, or mechanical engineering, mathematics, or physics; alternatively, 5 years of relevant experience with an advanced degree in one of these disciplines.
- Experience with IEC 62304, ISO 80002-1, ISO 14971, IEC 60601, FDA Design Controls, and other medical-device standards.
- Experience with risk-based software validation, software test automation, and software development lifecycle processes.
- Expertise in data modeling and interpretation involving field product performance, log analysis, and reliability modeling.
- Ability to navigate quality systems, solve complex problems, make balanced risk decisions, build consensus, and communicate complex information to teams and executive management with minimal oversight.
- At least 2 years of experience in a regulated industry is preferred.
- Experience with AI/ML-based medical software, including SaMD or embedded AI, is preferred.
- Knowledge of cybersecurity and data privacy standards and regulations, including IEC 81001-5-1, ISO 27001, NIST, GDPR, and HIPAA, is preferred.
Benefits
- Market-competitive compensation including base pay, incentives, benefits, and equity.
- Day shift with a set schedule; the position is onsite weekly, with the percentage of onsite work defined by the leader.
- Vaccination proof may be required depending on the role and customer requirements.
- The role may be subject to U.S. export-control licensing or a Technology Control Plan, which can affect the hiring timeline.
- The position is an employee role and may be filled at a different job level based on business need and the selected candidate’s experience, knowledge, and skills.
Categories
About Intuitive
Intuitive designs and manufactures robotic-assisted systems for minimally invasive procedures used by hospitals and surgeons, including the da Vinci surgical system and the Ion endoluminal platform for lung biopsy. Its business model combines capital equipment sales with recurring revenue from instruments, accessories, software, and service/training contracts. Founded in 1995 and headquartered in Sunnyvale, California, Intuitive is publicly traded on NASDAQ (ISRG) and serves healthcare providers worldwide.