Senior Supplier Development Engineer

Position Title: Senior Supplier Development Engineer
Work Location: Irvine, CA 92606
Assignment Duration: 18 Months
Work Arrangement: Onsite

Position Summary:

• Our Senior Supplier Development Engineer position is a unique career opportunity that could be your next step towards an exciting future.
• The Senior Supplier Development Engineer role will reside in the Advanced Technology (AT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease.

Key Responsibilities:

• Conduct engineering activities from 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 supplier part capability.
• Work directly with suppliers to address specifications and quality requirements.
• Lead supplier validation activities, support initial builds and commercialization of new product introduction.
• 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 review and manage design transfers to manufacturing.
• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition 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 and The Organization 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 in alignment on outstanding issues in a timely manner.
• Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as 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.
• Perform other duties and responsibilities as assigned.

Qualification & Experience:

• Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years’ experience including either industry or industry/education OR
• Master's Degree or equivalent in Engineering or Scientific field with, 3 years’ experience including either industry or industry/education.
• On-site work required.
• 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, minimally invasive endoscopy and implantable devices.
• CAD experience using ProE/Solidworks
• Strong analytical, problem solving and technical writing skills.
• Strong Project management 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.

Key Responsibilities:

• Conduct engineering activities from 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 supplier part capability.
• Work directly with suppliers to address specifications and quality requirements.
• Lead supplier validation activities, support initial builds and commercialization of new product introduction.
• 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 review and manage design transfers to manufacturing.
• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition 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 and The Organization 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 in alignment on outstanding issues in a timely manner.
• Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as 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.
• Perform other duties and responsibilities as assigned.