Staff Supplier Manufacturing Engineer, NPI - Machining

Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers.

Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports NPI and monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

The ideal candidate possesses broad and deep hands-on machining and secondary process operations such as passivation, heat treatment, electropolishing, and the like. The scale and impact this candidate will have on Intuitive's core business and products is very high, and self-motivated and driven candidates are encouraged to apply.

The chosen candidate will work with highly specialized internal and external SMEs, and have autonomy over multiple key decisions.

- 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. - 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 & build preferred suppliers

- Minimum10 years related experience in engineering and/or manufacturing processes - 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 - 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 - Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information

- BS degree in Engineering (Mechanical, Industrial, Manufacturing, Polymer Science etc.) or equivalent experience, advanced degree preferred

- Ability to travel to suppliers on an as-needed basis (~25%) - domestic and international

- New product development experience is a plus - Experience & examples of design transfer of NPI components, and production ramp-up of complex components are highly desirable

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

Required Skills and Experience

• Minimum10 years related experience in engineering and/or manufacturing processes
• 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
• 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
• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information

• BS degree in Engineering (Mechanical, Industrial, Manufacturing, Polymer Science etc.) or equivalent experience, advanced degree preferred

• Ability to travel to suppliers on an as-needed basis (~25%) – domestic and international

• New product development experience is a plus
• Experience & examples of design transfer of NPI components, and production ramp-up of complex components are highly desirable Primary Function of Position

Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers.

Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports NPI and monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.

The ideal candidate possesses broad and deep hands-on machining and secondary process operations such as passivation, heat treatment, electropolishing, and the like. The scale and impact this candidate will have on Intuitive’s core business and products is very high, and self-motivated and driven candidates are encouraged to apply.

The chosen candidate will work with highly specialized internal and external SMEs, and have autonomy over multiple key decisions.

• 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.
• 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 & build preferred suppliers