Mechanical Design Engineer

Job Description:
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 provide DFM input to new designs. Supports both NPI and on-going 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 moulding (MIM), metal machining manufacturing and/or plastic injection moulding experience along with skills to select and develop suppliers.
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 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, analysed 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.

Requirements:

• Minimum Education: BS degree in Mechanical or Biomedical Engineering or equivalent experience, advanced degree preferred.
• Minimum 4 years 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 modelling 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%).