Intuitive · 2 days ago
Staff Quality Engineer
San Francisco, CA
Full-time
Onsite
Lead/Staff
12+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Staff Quality Engineer will support product development from concept through commercialization, providing expertise in design control and risk management to ensure products meet quality standards and regulatory requirements.
Health CareManufacturingMedical Device
Responsibilities
Design Control and Risk Management Stewardship: Planning and execution of design controls, risk management, and design verification/validation for new products
+ Advocate product design history file and ensure compliance with internal processes and external standards and regulations
+ Understand user needs and assure they are translated to the design, while ensuring compliance with usability and human factors standards and regulations
+ Partner with engineering to define design inputs, design outputs, and traceability matrices
+ Contribute to the strategy and execution of risk-based design verification and validation
+ Accountable for overall risk management file: participate and support the development of product risk management file, to analyze and assess the product risks associated with user, design, process and supplier
Support design controls activities associated with new product development. Advocate and ensure the transfer of reliable and scalable designs to manufacturing
+ - Review and provide feedback on design architecture, selections, requirements, and drawings from early design
Collaborate with manufacturing, purchasing, test engineering, and supplier engineering to facilitate transfer of scalable designs into production
Contribute to new product development Technical Reviews and Design Reviews
Support Regulatory Affairs with creating submissions and responding to submission questions
Author CAPAs to ensure implementation of timely and effective corrective & preventive actions
Perform and/or support audits (internal, external, and by regulatory agencies)
Provide quality engineering support for the company’s contract manufacturing operations
Coach, mentor, teach, and influence the engineering staff in best quality practices, data analysis, protocol development, and design for quality and reliability methods
Qualification
Required
Education: Bachelor's degree in electrical, mechanical, biomedical or system engineering, math, or physics
Experience working with Energy Delivery products (e.g. Mapping Catheters, RF Ablation, Pulsed Field Ablation etc.)
12+ years of working experience in Quality Engineering or related field, minimum 6 years in medical device design environment specifically with Class II or Class III products
Advanced expertise in design control and risk management from early design and development through commercialization and demonstrated experience with electromechanical systems
Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization
Able 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
Able to articulate complex information to teams, including executive management
Preferred
Advanced degree preferred
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
GlobeNewswire
2026-01-23
2026-01-23
Company data provided by crunchbase