Senior / Supplier Development Engineer (Medical Device) - Up to 8K / EAST #HHL

Job Responsibilities:Complete purchased part qualification process deliverables including Supplier Process Failure Mode Effects Analysis, Inspection Reports, Gage R&R (repeatability and reproducibility), and Process Capability Analysis.Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.Select the right supplier and process for the part, considering long term fit and total cost of ownership.Support design changes to product requirements as necessary by initiating and managing changes to specifications and drawings through the engineering change order process.Manage supplier changes including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.Drive suppliers to continually improve their business and manufacturing process performance to meet Bio-Rad’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, Statistical Process Control (SPC), and negotiation.Lead these efforts without managerial guidance at several suppliers simultaneously.Provide effective and timely supply base health information and recommendation to management by creating and delivering data-driven supply base information, and prepare and deliver supplier communications as required by independently working with suppliers on scorecard creation.Requirement:Min. Bachelor degree in Engineering, advanced degree preferred. Minimum 5 years related experience in engineering and manufacturing of Printed Circuit Board Assemblies (PCBAs), metal components, and/or plastic injection molding. Experience working in medical devices industry is desirable. Excellent written and verbal communication skills including presentations to executive level management. 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 should include one or more in metal fabrication, plastics (injection molding), electronics, and/or contract manufacturing). Knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards).

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