Sr. Supplier Process Engineer

Intuitive•Sunnyvale, CA

About The Position

The Sr. Supplier Process Engineer ensures suppliers meet Intuitive Surgical (ISI) requirements for quality, service, delivery, and cost. The role drives continuous improvement across supplier manufacturing and business processes, supports supplier selection with cross-functional partners, and improves supplier performance, production scale-up, and product and process outcomes in collaboration with design and manufacturing teams. The position leads supplier projects involving product quality, cost, capacity, risk mitigation, supply continuity, and new manufacturing technologies. The role calls for broad process experience in metal machining and/or plastic injection molding and extrusions, along with the ability to assess and develop supplier partners and mentor others. The engineer manages complex supplier and manufacturing changes, completes and leads supplier qualification activities, and drives cost, capacity, and risk mitigation projects. The role also owns supplier nonconformances and corrective actions, manages changes to supplier requirements and documentation, develops supplier performance metrics, and provides management with data-driven information about supply-base and component inventory health. The engineer works across internal teams and external suppliers, prioritizes concurrent projects, and communicates technical and project information to stakeholders.

Requirements

Bachelor of Science degree in Engineering or equivalent.
Minimum 8 years of related experience in Supplier Engineering, Supplier Quality Engineering, and/or a related field.
Demonstrable knowledge of supplier part qualifications, supplier change controls, and design controls.
Demonstrable ability to evaluate and challenge supplier technical, quality, and business capabilities.
Proven history of implementing Lean, Six Sigma, and/or SPC programs at suppliers.
Knowledge of a wide range of manufacturing processes and their key quality, cost, and capacity input variables, such as metal fabrication, plastics, extrusions, electronics, and/or contract manufacturing.
Demonstrable knowledge of CAPA and SCAR processes, including containment, root cause analysis, corrective and preventive actions, and verification of effectiveness.
Excellent project management skills and experience influencing without formal authority.
Excellent written and verbal communication skills, including presentations to upper-level management.
Excellent interpersonal and team-building skills.
Excellent analytical, root-cause, and problem-solving skills, along with good judgment.
Excellent knowledge of 21 CFR Part 820 and ISO 13485.
Proficiency with Windows, Word, Excel, ERP information systems, and PLM systems.
Ability to travel to suppliers domestically and internationally as needed, approximately 25%.

Nice To Haves

Experience with one or more of these commodities: metal fabrication, plastics, extrusions, electronics, and/or contract manufacturing.
Medical device industry experience.
Experience auditing suppliers to 21 CFR Part 820 and ISO 13485.
Experience with GD&T, tolerance stack analysis, and CAD using 3D modeling tools.
Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
Proven ability to work alongside Design Engineering and assess supplier capability during design iteration.
Experience with statistical analysis software such as Minitab.
Experience with SAP ERP systems and Agile PLM systems.

Responsibilities

Manage complex supplier changes, including manufacturing process and design changes, production optimization, facility changes, new equipment qualification, and new line validations.
Complete part qualification deliverables, including First Article, supplier pFMEA, IQ/OQ/PQ process validations, inspection reports, Gage R&R, and process capability analysis; lead, train, and mentor suppliers through the process.
Partner with suppliers to deliver cost reductions, capacity improvements, and risk mitigation for high-severity parts, sole suppliers, and proprietary materials.
Participate in supplier selection, assessing suitable processes and suppliers, long-term fit, and total cost of ownership.
Drive supplier business and manufacturing process improvement using project management, Six Sigma, Lean, SPC, and negotiation practices, leading work across several suppliers without managerial guidance.
Own supplier nonconformances from initial symptoms through root cause analysis and corrective action, including Nonconformance Reports and SCAR documentation.
Initiate and manage Engineering Change Order changes to supplier documentation and specifications when ISI requirements need to change.
Develop and drive metrics for supplier part cost, delivery, quality, capacity, and capability.
Provide management with timely component inventory health information and recommendations using data-driven supply-base information.
Review, analyze, and close customer complaints, manufacturing nonconformances, and first article inspections; assess risk analyses and justifications and determine supplier corrective and preventive actions.
Work with suppliers to identify opportunities to prevent recurrence of issues.
Prioritize and advance multiple concurrent high-priority projects.
Integrate and distill communications across teams to provide cohesive internal and external messaging.
Build formal networks with key decision makers and serve as an external spokesperson for the organization.
Travel to suppliers domestically and internationally as needed, approximately 25%.