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Job Title: Endoluminal Supplier Engineer

Job Location: Sunnyvale, CA

Job Type: Contract

Job Description:

• The mission of Supplier Engineering is to build a world-class supplier network for our products that can ensure continuity of supply, scale to support demand, provide cost reduction and anticipate and mitigate supply chain risks.
• Supplier Engineers work throughout the product development lifecycle executing strategic projects to optimize commodities, sub-commodities, and individual suppliers, executing detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management and launch new products.
• This role will focus on manufacturing mechanical parts and assemblies of parts manufactured using all major manufacturing methods including CNC, sheet metal, plastic injection molding, extrusions, and electronics.
• The ideal candidate has experience bringing complex electro-mechanical devices market, has worked directly with manufacturing suppliers and component suppliers; and has demonstrated knowledge in a variety of manufacturing technologies.

Roles and Responsibilities:

• Drive projects to continually improve supply base 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.
• Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
• Examples include supplier changes, manufacturing process changes, PPQPs, production optimization, facility changes, new equipment qualification, and new line validations.
• Improve quality and ensure continuous improvement with suppliers by utilizing structured problem-solving processes such as 8D, root cause analysis, corrective actions, etc.
• Manage quality discrepancies through the execution of quality notifications.
• Manage the planning and execution of supplier change management projects.
• Collaborate with suppliers and internal stakeholders to determine deliverables and define timelines.
• Complete project deliverables including Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
• Effectively prioritize and advance multiple concurrent projects and tasks.
• Clearly communicate project status to key stakeholders.

Requirements:

• Minimum BS degree in Engineering or equivalent experience.
• Minimum 2+ years in engineering and manufacturing, preferably in the medical, automotive, or aerospace industries.
• Excellent written and verbal communication skills including presentations to executive level management.
• Outstanding analytical skills along with good judgment.
• Ability to find common ground between various stakeholders, and bring people together to drive towards key goals.
• Knowledgeable of GD&T, certification is a plus.
• Knowledge of 21 CFR part 820 and ISO 13485 is a plus.
• Proficient in MS Office and ERP Information Systems, preferably SAP.
• Experience in a high-volume medical device company is a plus.
• Ability to travel to suppliers on an as needed basis – domestic and international.

Skills:

• Polymer extrusion qualification and contract manufacturing experience.
• Plastics injection molding qualification and contract manufacturing experience.
• Electrical Engineering with PCA and PCB experience.