Intuitive · 1 day ago
Component Engineer 4
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$161K/yr - $231K/yr
10+ years expIntuitive is a company focused on innovation in the medical device industry. The Component Engineer 4 will be responsible for ensuring suppliers meet quality and performance requirements while driving continuous improvement in manufacturing processes and supplier relationships.
Health CareManufacturingMedical Device
Responsibilities
Select, evaluate, and qualify suppliers
Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans
Supplier Corrective Action Request initiation, execution, and closure
Ensure compliance to quality management system and regulatory requirements by leading and mentoring auditors for QMS audits
Lead detailed projects of transfers of the supply of products and components
Create strategies to effectively optimize the supply base by leading efforts to optimize supply networks
Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical’s requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation by leading these efforts without managerial guidance at several suppliers simultaneously
Develop and influence using metrics for supplier part cost, delivery, quality, capacity and capability by creating metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity
Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions
Drive changes to ISI specifications through influencing and educating resulting in changing specifications and drawings including driving the ECO process to implementation
Provide effective and timely supply base health information to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance (including QRB) and provide recommendations
Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation of QBRs, Supplier Summits, etc
Facilitate supplier contract development to execution and maintenance by negotiating contracts as necessary in collaboration with the contract team and Supply Chain Management
Manage the ASL and Global Commodity Matrix
Work with suppliers and ISI engineering for the new product introduction to: Create product supplier landscapes to determine launch readiness and report to management
Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability
DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production
Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers
Deliver the following Quality deliverables: pFMEA, Special Process Validations, FAI, and Cpk by leading, training and mentoring suppliers through the pFMEA development, judging process validation requirements and signing-off on protocols as ISI rep, judging process capability with supplier as well as judging FAI suitability
Develop the supplier business continuity / disaster recovery plans by managing suppliers to create plans, judge plans for risks and negotiate with suppliers to reduce risks. Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management
Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications, determining corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence
Qualification
Required
BS degree in Engineering or equivalent, experience in machining commodity
Preferred
Minimum 10 years related experience in Supplier Engineering/Development/Quality or related field
Excellent written and verbal communication skills including presentations to executive level management
Excellent Interpersonal skills and team building skills
A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers
Excellent Project Management skills
Excellent analytical and problem solving skills along with good judgment
Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)
Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards)
Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP
CAD experience with 3D modeling tools is a plus
Proven ability to motivate suppliers
Experience in a high-volume medical device company is a plus
Ability to read and interpret detailed mechanical drawings and communicate technical information
Ability to travel to suppliers on an as needed basis – domestic and international
Benefits
Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
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
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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