Sr Supplier Manufacturing Engineer, NPI Metals/Plastics

Intuitive•Sunnyvale, CA

About The Position

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 metal injection molding (MIM), plastic injection molding (PIM), and/or machining experience along with skills to select and develop suppliers. 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.

Requirements

Minimum 5 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
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

Nice To Haves

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

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.
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.
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
Other reasonable duties