This role will focus on manufacturing of electronics including printed circuit boards (PCBs), printed circuit board assemblies (PCBAs), electronic components, sub-assemblies, and fully finished electronic systems for some of Intuitive’s newest products. The ideal candidate has experience bringing electronic devices to market, preferably medical devices; has worked directly with electronics manufacturing service (EMS) suppliers and component suppliers; and has demonstrated knowledge in a variety of electronics manufacturing technologies such as surface mount technology (SMT), automatic optical inspection (AOI), in-circuit test (ICT), functional testing (FUT), cable assemblies, etc.; as well as electronic system and PCBA design experience.
Essential Job Duties:
• 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 risk mitigation.
• 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.
• Provide effective and timely supply base health information and recommendation to management by creating and delivering data-driven supply base information to any level of management at ISI with little or no guidance.
• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
• 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.
• 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 variance requests, and first article inspections by judging risk analyses and justifications.
• Evaluate corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence.
Required Skills and Experience
• Minimum 8 years related experience with an BS Engineering degree or 6 years’ experience with MS in Engineering, or 3 years’ experience with PhD.
• Excellent written and verbal communication skills including presentations to executive level management.
• Excellent Interpersonal skills and team building skills.
• 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).
Required Education and Training:
• Minimum Education: BS degree in Engineering, advanced degree preferred.
• Experience with statistical analysis software such as Minitab
• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
Agile and SAP experience preferred.
Working Conditions
• Ability to travel to suppliers on an as-needed basis – domestic and international.
Preferred Skills and Experience
• CAD experience with 3D modeling tools
• Experience in a high-volume medical device company