Job Description

Job Description:

• Responsible for ensuring suppliers meet company 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 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 possesses broad and deep hands-on metal injection molding (MIM), metal machining, manufacturing and/or plastic injection molding experience along with skills to select and develop suppliers.

Requirements:

• Minimum Education: BS degree in Mechanical or Biomedical Engineering or equivalent experience, advanced degree preferred.
• Minimum 4 years of related experience in engineering and manufacturing of metal injection molding (MIM), machined metal or plastic injection molding parts.
• Metal injection molding experience is highly desirable.
• 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).
• 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.
• 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.
• Ability to travel to suppliers on an as-needed basis – domestic and international (approx 25%).

Roles & 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 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 company 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 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 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.
• Provide effective and timely supply base health information and recommendations to management by creating and delivering data-driven supply base information to any level of management at company with little or no guidance.
• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
• 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 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, look for opportunities with suppliers to eliminate recurrence.

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