Sr. Manufacturing Supplier Development Engineer

Job Title:

Sr. Manufacturing Supplier Development Engineer

Pay Rate: $60 to $65.67/Hr

Duration: 18 Months

Location:

Irvine, CA (Onsite)

Our Client is a Global medical device Manufacturer.

We are looking for a Sr. Manufacturing Supplier Development Engineer to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from the initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools, and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs.

Assess and develop the supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds, and the commercialization of new product introductions. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory, and clinical requirements. Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to manufacturing.

• Provide technical input for strategic sourcing projects, including evaluation of supplier capabilities, part qualification plans, specification reviews, product implementations, and part transitions to manufacturing.
• Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
• Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
• Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices), and custom materials, including supplier validations are receiving inspection fixture design for Test method validation.
• Respond with a high sense of urgency to quality issues and escalate/communicate appropriately.
• Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
• Strategically bring various cross-functional teams and suppliers into alignment on outstanding issues in a timely manner.
• Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing and remove any waste from processes.
• Develop and manage project milestones in line with development and commercialization needs.
• Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
• Audit suppliers for their technical capabilities as well as quality criteria.

Requirements:

• Bachelor's Degree or equivalent in Engineering or a Scientific field with 4 years’ experience, including either industry or industry/education, OR Master's Degree or equivalent in Engineering or a Scientific field with 3 years’ experience, including either industry or industry/education.
• Up to 20% domestic/international travel required.
• Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
• Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices would be preferred, minimally invasive endoscopy and implantable devices.
• CAD experience using ProE/Solidworks.
• Strong analytical, problem-solving, and technical writing skills.
• Ability to work well both independently and as a member of a team.
• Effective verbal/written communication and interpersonal skills including conflict and relationship management.