Description

• 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 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 Client 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 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%)

Key Skills

Education

Bachelor's degree