Staff Supplier Manufacturing Engineer, Machining

Intuitive•Sunnyvale, CA

2d•$158,400 - $268,100•Onsite

About The Position

This role is responsible for ensuring suppliers meet Intuitive Surgical Inc. (ISI) requirements for quality, service, delivery, and cost. The engineer will drive suppliers to continuously improve their business and manufacturing processes, evaluate and select suppliers, and guide Engineering in choosing suppliers for new products while providing Design for Manufacturability (DFM) input. The position supports both New Product Introduction (NPI) and ongoing production, monitors and works with suppliers to improve performance, and executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management. The ideal candidate will have broad and deep hands-on experience in metal injection molding (MIM), plastic injection molding (PIM), and/or machining, along with the skills to select and develop suppliers. This role has a high scale and impact on Intuitive’s core business and products. Self-motivated and driven candidates are encouraged to apply.

Requirements

Minimum 8 years related experience in engineering and manufacturing of metal injection molding (MIM), plastic injection molding(PIM), and/or Machining.
Hands on plastic injection molding experience is highly desirable, including but not limited to Scientific Injection Molding (SIM) principles, plastic DFM, Silicone molding (LSR and/or compression molding).
Excellent written and verbal communication skills including presentations to executive level management and technical SMEs within Design Engineering, Manufacturing Engineering, & Supplier Engineering.
Excellent Interpersonal skills and team building skills. Ability to build and foster great working relationships with external suppliers is invaluable.
A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers.
Excellent Project Management skills.
Excellent analytical and problem solving skills along with good judgment.
Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing).
Excellent knowledge of 21 CFR part 820 and ISO 13485.
Significant computer experience using Windows, Word, Excel, Project, Access, and ERP Information Systems, preferably SAP or Agile.
Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
Ability to travel to suppliers on an as needed basis – domestic and international.

Nice To Haves

CAD experience with 3D modeling tools is a plus, such as SolidWorks.
Experience with statistical analysis software such as Minitab is a plus.
Proven ability to motivate suppliers.
Experience in a high-volume medical device company is a plus.
New product development experience is a plus.
Advanced degree preferred.

Responsibilities

Complete project/part qualification deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
Work with suppliers to execute cost reductions, capacity improvements, and supply chain risk mitigation efforts like dual sourcing or supplier driven design improvements.
Select the right process and supplier for the part, considering long term fit and total cost of ownership.
Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
Drive changes to ISI requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.
Own and drive to closure supplier variances from symptom through root cause analysis to corrective action, including careful CAPA documentation.
Effectively prioritize and advance multiple concurrent projects and tasks.
Clearly communicate project status to key stakeholders.
Build, own, and relentlessly pursue a vision for developing suppliers.
Understand proper level of documentation detail for tracking of actions and justification of decisions.
Generate key metrics for the team and suppliers, and continually drive for timely achievement of those metrics.
Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
Implement corrective and preventive actions for supplier process by driving supplier’s investigations and root cause analysis, reduce issue recurrence through thorough RCA implementation.
DFM by engaging suppliers early in development cycle to feedback manufacturability improvements in the designs prior to production.
Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate & build preferred suppliers.
Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications.
Work with suppliers and ISI engineering for the new product introduction to create product supplier landscapes to determine launch readiness and report to management, develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability.
Collaborate with Supply Chain & purchasing organizations to ensure new suppliers meet financial and viability thresholds to onboard onto Intuitive Approved Supplier List.