Intuitive · 2 months ago
Manager Instruments Manufacturing Engineering
Sunnyvale, CA
Full-time
Onsite
Mid, Senior Level
5+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to enhancing minimally invasive care. The Manager of Instruments Manufacturing Engineering will lead a team responsible for creating precision instruments, ensuring product quality and compliance, and supporting new product introduction (NPI) projects.
Health CareManufacturingMedical Device
Responsibilities
Lead a team of Product Manufacturing Engineers, in collaboration with other organizations, to support production of complex products with responsibilities including but not limited to:
Establish group and individual objectives, priorities, and metrics
Ensure fulfillment of product development goals for NPI projects
Ensure the professional development of individual team members
Ensure production of products meets expected output
Ensure quality requirements are fulfilled and maintained
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
Provide technical support for failure analysis and root cause investigation of product failures
Plan, budget and staff projects, tracking performance throughout
Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary
Work with Quality group to ensure that the team follows appropriate Good Manufacturing Processes (GMP), design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures
Improve product quality, yields, and reduce cost
Improve the manufacturing process as needed
Complete cost analysis and lead cost reduction efforts
Mentor and train new employees
Create, maintain and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions
Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (DQ/IQ/OQ//PQ)
Provide production line support for day-to-day engineering issues on core instrument and NPI lines
Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction
Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns
Other related duties
Qualification
Required
Successful experience leading projects
Minimum of five years' engineering experience manufacturing complex electro-mechanical products
Ability to motivate, mentor, and inspire a high capacity technical team
Prior responsibility for validation of processes, equipment and products
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK
Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers
Able to travel periodically to suppliers or Intuitive Mexicali plant
Minimum B.S. degree in engineering discipline, M.S. preferred
Preferred
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment
Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments
Prior experience with Class III medical devices
Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software
Experience developing products from early stage concept to volume manufacturing
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
2025-12-11
2025-11-14
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