Sr Supplier Engineer

Intuitive•Sunnyvale, CA

About The Position

Intuitive Surgical is seeking a Senior Supplier Engineer to help ensure high-quality, stable delivery of purchased production components from suppliers operating under robust quality systems. The role is responsible for helping suppliers meet Intuitive Surgical requirements for product quality, cost, and service, with patient safety as the highest priority. The engineer supports supplier part qualification, value engineering, quality improvement, manufacturing process selection and development, supplier change management, supplier selection and evaluation, and supplier relationship development. The position works across internal teams and with suppliers to assess technical and operational capabilities, address production issues, and establish effective, sustainable manufacturing processes. Supplier visits may be required domestically and internationally as needed.

Requirements

Bachelor of Science degree in an engineering field.
At least 8 years of related experience in manufacturing, supplier process engineering, design, or a related field.
Excellent written and verbal communication skills.
Experience creating and aggregating DFM feedback.
Demonstrable ability to evaluate and challenge suppliers’ technical, quality, and business capabilities.
Experience with a wide range of manufacturing processes and understanding of key input variables affecting quality, cost, and capacity.
Proven ability to motivate suppliers and lead teams in solving difficult technical and process problems.
Knowledge of pFMEA, process validation, inspection, and test techniques.
At a minimum, understanding of GDP and QMS methods.
Significant computer experience using Windows, Word, Excel, Access, and ERP information systems.
Ability to read and interpret detailed specifications and schematics, and communicate technical information.
Ability to travel to supplier sites domestically and internationally as needed.

Nice To Haves

Experience with machining, including 4- and 5-axis holdings, FMS, and bar-fed lathes.
Experience with plastic injection molding or other plastic forming processes.
Experience with die casting or Thixomolding.
Familiarity with 21 CFR Part 820 and ISO 13485.
Experience auditing suppliers to 21 CFR Part 820 and ISO 13485.
Experience using SAP.
Experience in a medical device company.
Experience with low-volume, high-mix production environments.

Responsibilities

Support part qualification, value engineering, and quality improvement efforts.
Lead Core Product Teams in defining appropriate part qualification requirements, including testing and inspection requirements before system integration.
Support transfers of parts between suppliers.
Complete production part qualification deliverables, including supplier pFMEA, special process validations, FAI, and process capability analysis.
Perform product and process risk analyses, and ensure mitigations are implemented and effective before product introduction.
Establish sustainable process capability at suppliers and critical sub-tier suppliers.
Support manufacturing-line escalations and drive corrective actions using root-cause tools such as 8D and 5 Why.
Identify true root causes and implement effective, lasting corrective and preventive actions.
Lead manufacturing process selection, considering process quality, long-term capacity, and total lifecycle cost.
Identify opportunities for design for manufacturability (DFM) to improve quality, reduce costs, or increase supply-chain capacity.
Educate internal customers and suppliers about supplier quality, process and operational capabilities, and suitable manufacturing methods and tooling.
Propose and manage changes to specifications and drawings through the ECO process to improve Intuitive Surgical requirements as needed.
Plan and implement supplier change-management projects using the Supplier Change Request process after Design V&V.
Report supply-chain readiness for major production process changes, including quality, capacity, and delivery.
Work cross-functionally to improve supplier engineering processes.
Support supplier selection by working with Product Design, Commodity Managers, and other stakeholders to identify capable suppliers for new products.
Evaluate new suppliers through informal assessments and formal assessments, including supporting lead auditors in quality management system evaluations.
Support audit teams in addressing findings and developing suppliers’ quality and business systems to meet Intuitive Surgical requirements.
Manage supplier relationships to foster effective partnerships.