Supplier Manufacturing Engineer

Infosoft, Inc.; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in medical devices is looking for a Supplier Manufacturing Engineer in Irvine, CA. The role involves providing engineering support for implantable devices and engaging with suppliers to optimize manufacturing processes. Candidates should have a relevant degree and experience in supplier development with capabilities in statistical tools.

Qualifications

• 4 years’ experience in industry or education for Bachelor’s.
• 3 years’ experience in industry or education for Master’s.
• Up to 20% travel required.

Responsibilities

• Provide manufacturing engineering support in product development.
• Conduct reviews to ensure Design for Manufacturability is used.
• Lead supplier validation activities and manage design transfers.

Skills

Analytical skills

Problem solving

Technical writing

Communication

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree in Engineering or Scientific field

Tools

Statistical tools (SPC, Six Sigma, DMAIC)

CAD (ProE/Solidworks)

Job description

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Base pay range

$60.00/hr - $65.67/hr

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Job Title: Supplier Manufacturing 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 Senior 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 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 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 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 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.

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.

Preferred Skills:

• 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.
• 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering, Manufacturing, and Other

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care

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