Component Engineer 4 - Overmolding Molding / Metal Injection Molding (MIM)

Notes ISI WOW: Onsite Strong experience in component engineering / supplier engineering Hands-on expertise in: Detailed machining, Overmolding, Molding / Metal Injection Molding (MIM) / coatings Knowledge of medical device manufacturing processes or equivalent regulated environments Experience with: PPAP / PPQPs (Production Part Approval / qualification processes), Process validation, SPC (Statistical Process Control), Control plans Ability to develop and execute process documentation Understanding of process capability analysis Experience in product/component development Ability to work independently with high ownership Strong analytical and problem-solving skills Willingness to travel (primarily within the US, occasional Asia travel) Job Description Summary 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 providing DFM input to new designs. Supports both NPI and ongoing production, 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 has a track record of supporting new products launch, demonstrated collaboration with Contract Manufacturers, and preferred experience with multiple manufacturing methods, including various metal/plastics machining processes, treatments, and finishing processes. Plastic Injection Molding and Metal Injection Molding are preferred as well. The candidate also has skills in selecting and developing suppliers. 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 providing DFM input to new designs. Supports both NPI and ongoing production, 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. Roles & Responsibilities Complete Part Qualification (PPQP) 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 symptoms 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 the 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 the 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 the supplier process by driving the supplier’s investigations and root cause analysis. 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 the development cycle to provide feedback on 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 and look for opportunities with suppliers to eliminate recurrence. Skills, Experience, Education, & Training Minimum 8 years related experience with a BS Engineering degree or 6 years’ experience with an MS in Engineering Excellent written and verbal communication skills, including presentations to executive-level management. Excellent interpersonal skills and team-building skills. 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 (Machining, Plastic Injection Molding, Metal Injection Molding, and/or knowledge in Contract Manufacturing) Proven ability to lead teams to solve difficult technical and process problems Proven ability in New Product Introduction and rapid scaling in production Proficient in pFMEA, process validation, root cause investigation, inspection, and test techniques Knowledge of document management systems and ERP Systems, preferably Agile and SAP Knowledge of 21 CFR part 820 and ISO 13485 preferred Excellent written and verbal communication skills, including presentations to executives Experience in a high-volume medical device company is a plus Ability to travel to suppliers on an as-needed basis – domestic and international (approx. 25%) APNSoftware services Inc. is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. #J-18808-Ljbffr APN Software Services, Inc