Component Engineer

Intuitive•Sunnyvale, CA

15h

About The Position

The Component Engineer is responsible for ensuring suppliers meet Intuitive Surgical (ISI) requirements for cost, quality, delivery, and service, while driving continuous improvement in supplier business and manufacturing processes. The role evaluates, selects, and qualifies suppliers; supports R&D Engineering with supplier selection and design-for-manufacturability (DFM) input; and supports both new product introduction (NPI) and ongoing production by monitoring and improving supplier performance. This position leads supplier qualification, process improvement, corrective actions, audits, product and supply transfers, supply-base optimization, and supplier performance measurement. It works with suppliers, Engineering, Supply Chain Management, and other stakeholders to support product launches, improve manufacturability and quality, manage supply risks, reduce costs, and maintain compliance with quality-system and regulatory requirements. The position also provides data-driven supply-base health information and recommendations to management, develops supplier communications and contracts, and manages the Approved Supplier List (ASL) and Global Commodity Matrix. The role may require domestic and international travel to suppliers as needed. Intuitive notes that vaccination proof may be required depending on the role or customer. Compensation is market competitive and includes base pay, incentives, benefits, and equity; the posting says actual pay depends on factors such as experience, skills, qualifications, and job level, but provides no specific compensation figures.

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/or SPC programs at suppliers.
Excellent project-management skills.
Excellent analytical and problem-solving skills, with good judgment.
Demonstrable knowledge of evaluating and challenging suppliers’ 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 computer 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 domestically and internationally as needed.

Nice To Haves

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

Responsibilities

Select, evaluate, and qualify suppliers.
Lead part qualification activities, including pFMEAs, FAIs, Cpk assessments, and Control Plans.
Initiate, execute, and close Supplier Corrective Action Requests.
Ensure compliance with the quality management system and regulatory requirements, including 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 improvements in business and manufacturing processes using project management, Six Sigma, Lean, SPC, negotiation, and related best practices, including ship-to-stock programs.
Develop and use metrics for supplier part cost, delivery, quality, capacity, and capability to measure improvement and determine supplier or commodity interventions.
Drive supplier corrective actions through root-cause analysis and corrective and preventive actions.
Influence and drive changes to ISI specifications and drawings, including the ECO process through implementation.
Prepare and deliver data-driven supply-base health information and recommendations to management, including QRB reporting, with little or no guidance.
Prepare and deliver supplier communications, including supplier 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.
Support NPI by creating supplier landscapes, assessing launch readiness, and reporting findings to management.
Develop supplier ramp-readiness plans based on forecast, supplier capacity, quality performance, process capability, and business risk.
Engage suppliers early in development to provide DFM feedback and improve designs before production.
Guide Engineering in supplier selection by determining preferred-supplier criteria and leading evaluation efforts.
Deliver quality activities including pFMEAs, special-process validations, FAIs, and Cpk assessments; train and mentor suppliers, judge validation requirements and process capability, and sign off on protocols as an ISI representative.
Develop supplier business-continuity and disaster-recovery plans, assess their risks, and negotiate with suppliers to reduce risks.
Identify and investigate cost-reduction and quality-improvement opportunities; develop data-driven strategies and plans for management.
Review, analyze, and close customer complaints, manufacturing variance requests, and first-article inspections; assess risks and justifications, determine supplier corrective and preventive actions, and seek ways to prevent recurrence.
Travel to suppliers domestically and internationally as needed.