Intuitive · 1 day ago
Quality Engineer - Reprocessing Development
Sunnyvale, CA
Full-time
Hybrid
Mid, Senior Level
$123K/yr - $177K/yr
5+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. They are seeking a Quality Engineer to act as a central resource for cleaning, disinfection, and sterilization testing of reusable medical devices, collaborating with cross-functional teams to ensure compliance with regulatory submissions and improve workflows.
Medical DeviceHealthcareManufacturingHealth Care
Responsibilities
Lead multiple validation and verification studies including cleaning, disinfection, and sterilization involving rigorous data analysis with focus on the safety and efficacy of new robotic medical devices
Maintain reprocessing instructions for use (IFU) requirements including design control activities, harmonization of content across platforms, and continuous improvement
Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (vendors and laboratories)
Define reprocessing test approach and test plans to ensure safety and efficacy for new instrument and accessory products across the company’s product platforms. Provide subject matter expert input for design, materials, and product requirements for optimized reprocessing output
Collaborate with Regulatory Affairs to support domestic and international regulatory submissions and approvals
Collaborate with Product Management to integrate user needs into reprocessing instructions
Develop and maintain procedures and best practices to ensure compliance with applicable domestic and international cleaning, disinfection, and sterilization standards
Optimize cleaning, disinfection, and sterilization control processes, systems, and procedures
Support development of harmonized reprocessing manuals for end users, minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices
Good working knowledge of medical device industry standards and guidance for medical device reprocessing
Support field teams and other global teams across the organization on technical inquiries related to reprocessing
Support field visits to central reprocessing customer sites and make recommendations for improvements to streamline reprocessing workflows
Participate in AAMI working groups in the development of new standards in this field
Other duties as assigned
Qualification
Required
BS in Engineering, Life Science, Microbiology or technical equivalent; Masters is preferred
Minimum of 5 years of experience in the medical device field
Familiarity with US and international medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, AAMI ST98, AAMI ST91, ISO 15883, ISO 17665, and ISO 17664
Superior verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents
Self-starter with ability to lead in a fast-paced environment
Able to prioritize and manage multiple projects and focus execution
Hands-on experience with proven ability to work well in cross-functional team environment and meet project goals
Attention to detail along with flexibility to support various projects
Well versed in MS Office Suite including statistical analysis tools
Ability to travel to customer or laboratory sites (10%), including international travel
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