Senior Component Engineer

Job description

Job Description:



Pay Range: $50.97hr - $63.64hr



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 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 company 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 with little or no guidance.
  
  


• Prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.
  
  


• Work with suppliers and design 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 Design 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 Other reasonable duties.
  
  

• Minimum 3 years related experience in engineering and manufacturing of precision sheetmetal, CNC machined metal, or plastic injection molding parts.
  
  


• 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.
  
  


• Proven ability to motivate suppliers.
  
  


• Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
  
  


• Required Education and Training.
  
  

• BS degree in Engineering or equivalent experience, advanced degree preferred


• CAD experience with 3D modeling tools is a plus.
  
  


• Experience with statistical analysis software such as Minitab is a plus.
  
  


• Experience in a high-volume medical device company is a plus.
  
  

• Ability to travel to suppliers on an as-needed basis domestic and international.
  
  

• Medical Device experience is a plus.
  
  


• Supplier management experience is a plus.
  
  


• Advanced degree preferred.
  
  


• CAD experience with 3D modeling tools is a plus.
  
  


• Experience with statistical analysis software such as Minitab is a plus.
  
  


• Experience in a high-volume medical device company is a plus.
  
  

Required Skill Profession

Architecture And Engineering