Senior Supplier Process Engineer

Intuitive•Sunnyvale, CA

3d•Hybrid

About The Position

Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive both suppliers and internal teams to continuously improve both manufacturing and business processes. Evaluate and collaborate on supplier selection with cross functional partners. Support both NPI and ongoing production by engaging with suppliers to improve supplier performance, monitor product and process performance, scale-up production, and work with design and manufacturing teams to implement improvements. Lead and execute detailed supplier projects to implement changes affecting product quality, cost, capacity, risk mitigation/supply continuity, and integration of new manufacturing technologies. The ideal candidate possesses a broad process experience in metal machining and/or plastic Injection molding and extrusions, and has the skills and experience to assess and develop optimal supplier partners in these categories while mentoring others in this skillset.

Requirements

Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
Demonstratable knowledge of supplier part qualifications, supplier change controls, and design controls
A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers
Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost, and capacity (i.e. metal fabrication, plastics, extrusions, electronics, and/or contract manufacturing)
Demonstratable knowledge of CAPA process (specifically containment, root cause analysis, corrective/preventive actions)
Excellent Project Management skills and experience in influencing without formal authority
Excellent written and verbal communication skills including presentations to upper-level management
Excellent interpersonal skills 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 (experience in auditing suppliers to these standards preferred)
Proficiency with Windows, Word, Excel, ERP Information Systems (preferably SAP), and PLM Systems (preferably Agile)
BS degree in Engineering or equivalent.
Minimum 8 years related experience in Supplier Quality Engineering and/or Supplier Development or related field.

Nice To Haves

Experience with one or more of the following commodities is preferred: metal fabrication, plastics, extrusions, electronics, and/or contract manufacturing.
Experience in the Medical Device industry is preferred
Experience with GD&T, tolerance stack and CAD experience with 3D modeling tools is a plus
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 the design iteration process
Experience with statistical analysis software such as Minitab is a plus

Responsibilities

Partner with suppliers to execute cost reductions, capacity improvements, and risk mitigation projects for high severity parts, sole suppliers, or proprietary materials
Manage complex supplier changes including manufacturing process changes, design changes, production optimization, facility changes, new equipment qualification, and new line validations.
Complete part qualification deliverables including: First Article, Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis, and lead, train, and mentor suppliers through the process.
Participate in supplier selection process: selecting the right process and supplier for the part, considering long term fit, and total cost of ownership.
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 at several suppliers simultaneously, without managerial guidance.
Own and drive to closure supplier nonconformances from symptom through root cause analysis to corrective action, including Nonconformance Reports and SCAR documentation.
Drive changes to ISI requirements as necessary, by initiating and managing changes to specifications and drawings through the Engineering Change Order process
Develop metrics for supplier part cost, delivery, quality, capacity, and capability, and continually drive for timely achievement of those metrics.
Provide effective and timely component inventory health information and recommendations to management by creating and delivering data-driven supply base information.
Review, analyze, and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications, determining corrective and preventive actions at suppliers. Look for opportunities with suppliers to eliminate recurrence.
Effectively prioritize and advance multiple concurrent high priority projects. Effectively integrate and distill communications across multiple teams for cohesive and unified messaging both internally and externally. Create formal networks with key decision makers and serve as external spokesperson for the organization.
Work with suppliers and ISI New Product Development/Introduction Engineering 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., 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 preferred suppliers, Review, analyze and close customer complaints, manufacturing nonconformances, and first article inspections by judging risk analyses and justifications