Intuitive · 8 hours ago
Quality Engineer 2
Sunnyvale, CA
Full-time
Onsite
Mid Level
$104K/yr - $141K/yr
3+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Quality Engineer II will support product development from concept through commercialization, ensuring that products meet quality standards and regulatory requirements while collaborating with cross-functional teams.
Health CareManufacturingMedical Device
Responsibilities
Work closely with product development teams
Monitor priorities and tracks progress against schedules; and communicates status to management
Provide support in the implementation and policing of GMP, ISO and FDA requirements
Experience and excellent understanding of pFMEAs, Root Cause, CAPAs, Non-Conformance, and Process Validation
Experience with product investigation, Identifying root cause and implementing appropriate solutions
Familiarity with data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)
Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems
Experience with computerized systems, such as SAP, Trackwise, Agile, etc
Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes
Support Regulatory Affairs with creating submissions and responding to submission questions
Support internal and external audits, including preparation and direct interaction with auditors
Support manufacturing and work cross-functionally to resolve technical problems
Support, designs and implements methods and/or procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment
Author technical documents with sufficient clarity, detail and correctness
Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset
Other duties as assigned
Qualification
Required
Minimum Education: Bachelor's in engineering or STEM
Advanced degree preferred with 2+ years of working experience in Quality Engineering or related field, minimum 2 years in medical device environment
Experience and familiarity with respect to design control and risk management from early design and development through commercialization
Demonstrated experience with electromechanical devices
Experience with medical standards: ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls and design optimization
Able to navigate quality system 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 management
Minimum BS in Engineering or STEM discipline is required
Minimum 3 years of experience in a regulated industry with 1 years in Medical Device
Preferred
Experience with data analysis tool. i.e., Tableau, PowerBI, etc
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