Intuitive Surgical Careers
Senior Supplier Engineer - Core Instruments and Accessories
Primary Location: United States-California-Santa Clara County-Sunnyvale
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical (ISI) means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems to maximize Patient Value. Each supplier engineer is responsible for ensuring their Suppliers meet ISI requirements for product safety, quality, cost, delivery, and service.
Roles and Responsibilities:
• Drive suppliers to continually improve their business and manufacturing process performance to meet ISI’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation• Develop strategies for suppliers and influence key stakeholders to utilize and maximize the use of Preferred suppliers• Perform and maintain product/process risk analysis and ensure mitigations are implemented and effective (Supplier Process FMEA)• Investigate and resolve ISI Production line down events that are Supplier related; includes the following:• Disposition of non-conforming material (Containment)• In-depth Root Cause Analysis• Implementation of Corrective Actions/Preventive Actions• Participate in the Supplier Selection Evaluation team and ensure all Quality aspects of the intended Supplier are considered; may include:
o QMS audit and Control Plan audito Process Validationo Capacity Studies
• Participate in New Product Launches; may include:
o Selecting and Adding New Supplierso BOM Cost and Capacity Studieso Validation of equipment and processes at the Supplier
• Execute Lead Auditor function for assigned suppliers based on ISO 13485 clauses
• BS degree in Engineering or equivalent. Mechanical Engineering degree is highly preferred.• 8+ years related experience in Manufacturing Engineering, Supplier Quality Engineering, or related field• Excellent written and verbal communication skills• Dependable Project Management skills• In-depth analytical and trouble-shooting skills, and inspection and test techniques• Ability to read and interpret detailed specification drawings and communicate technical information• Experience in evaluating and supporting Supplier-related issues• Experience with a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity• Advanced computer experience using Windows, MS Office Suite, SAP (or other ERP system), and Agile (or other document control system)• Ability to travel to suppliers on an as needed basis – domestic and international (max travel per quarter is 30%)
• Knowledge of Supplier Process FMEA and Process Validation• Knowledge of Six Sigma and Lean Manufacturing techniques• Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards)• CAD experience with 3D modeling tools or schematic capture tools• Experience in a high-volume medical device company