Component Engineer

Intuitive•Sunnyvale, CA

2h•$136,500 - $231,000•Onsite

About The Position

The Component Engineer is responsible for ensuring suppliers meet Intuitive Surgical’s requirements for cost, quality, delivery, and service, while driving continual improvements to supplier business and manufacturing processes. The role evaluates and selects suppliers, advises R&D Engineering on supplier selection for new products, and provides design-for-manufacturability input. It supports both new product introduction and ongoing production, monitoring supplier performance and leading improvement efforts. The position leads supplier qualification, part qualification, corrective actions, audits, supply transfers, supply-base optimization, and supplier performance management. It develops and uses metrics, provides data-driven supply-base updates and recommendations to management, negotiates supplier contracts with relevant teams, manages the Approved Supplier List and Global Commodity Matrix, and prepares supplier communications such as scorecards and quarterly business reviews. For new product introduction, the role assesses supplier launch readiness, develops ramp-readiness and business-continuity plans, engages suppliers early to improve manufacturability, and guides Engineering in supplier selection. It leads suppliers through quality deliverables and process validation, and reviews customer complaints, manufacturing variance requests, and first article inspections to assess risk, establish corrective and preventive actions, and prevent recurrence. The role requires travel to suppliers domestically and internationally as needed.

Requirements

Bachelor of Science degree in Engineering or equivalent.
At least 10 years of related experience in Supplier Engineering, Supplier Development, Supplier Quality, or a related field.
Excellent written and verbal communication skills, including presentations to executive-level management.
Excellent interpersonal and team-building skills.
Proven history of implementing Lean, Six Sigma, and SPC programs at suppliers.
Excellent project management skills.
Excellent analytical and problem-solving skills, with good judgment.
Demonstrable knowledge of evaluating and challenging supplier technical, quality, and business capabilities.
Demonstrable knowledge of a wide range of manufacturing processes and the key input variables affecting quality, cost, and capacity.
Excellent knowledge of 21 CFR Part 820 and ISO 13485, including experience auditing suppliers to these standards.
Significant experience using Windows, Word, Excel, Access, and ERP information systems.
Proven ability to motivate suppliers.
Ability to read and interpret detailed mechanical drawings and communicate technical information.
Ability to travel to suppliers as needed, domestically and internationally.

Nice To Haves

Experience in the machining commodity.
Specialization in metal fabrication, plastics, electronics, and/or contract manufacturing.
Experience with SAP.
CAD experience with 3D modeling tools.
Experience in a high-volume medical device company.

Responsibilities

Select, evaluate, and qualify suppliers.
Lead part qualification activities, including pFMEAs, FAIRs, Cpk assessments, and Control Plans.
Initiate, execute, and close Supplier Corrective Action Requests.
Ensure compliance with the quality management system and regulatory requirements by leading and mentoring auditors for QMS audits.
Lead detailed projects to transfer the supply of products and components.
Develop strategies to optimize the supply base and supply networks.
Drive supplier improvement in business and manufacturing processes, including ship-to-stock programs, using project management, Six Sigma, Lean, SPC, and negotiation practices.
Develop and use metrics for supplier part cost, delivery, quality, capacity, and capability to measure improvement and determine intervention needs.
Drive supplier corrective actions through root-cause analysis and corrective and preventive actions.
Influence and guide changes to ISI specifications and drawings, including driving the ECO process through implementation.
Prepare and deliver data-driven supply-base health information and recommendations to management, including QRB, with little or no guidance.
Prepare supplier communications and independently work with suppliers on scorecards, QBRs, and Supplier Summits.
Facilitate supplier contract development, execution, and maintenance in collaboration with the contract team and Supply Chain Management.
Manage the ASL and Global Commodity Matrix.
Create supplier landscapes for new products to assess launch readiness and report findings to management.
Develop supplier ramp-readiness plans based on forecasts, supplier capacity, quality performance, process capability, and business risk.
Engage suppliers early in product development to provide design-for-manufacturability feedback before production.
Guide Engineering in supplier selection by defining criteria for preferred suppliers and leading supplier evaluations.
Lead, train, and mentor suppliers in quality deliverables, including pFMEAs, special-process validations, FAI, and Cpk; assess validation requirements and process capability and sign off on protocols as the ISI representative.
Develop supplier business-continuity and disaster-recovery plans, assess risks, and negotiate with suppliers to reduce risks.
Identify and investigate cost-reduction and quality-improvement opportunities, develop strategies, conduct research, and provide data-driven plans to management.
Review, analyze, and close customer complaints, manufacturing variance requests, and first article inspections; assess risks, determine supplier corrective and preventive actions, and help prevent recurrence.
Travel to suppliers domestically and internationally as needed.