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Senior Supplier Development Engineer
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-01-02
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-01-02
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title: Senior Supplier Development Engineer
Location: Irvine, CA
OverviewSenior Supplier Development Engineer within the Advanced Technology Supplier Development Engineering team, providing manufacturing engineering support for design, development, and commercialization of implantable cardiovascular devices and delivery systems. Partners with suppliers, sourcing, R&D, quality, and manufacturing to ensure DFM, supplier capability, and successful new product introduction.
Key Responsibilities- Support manufacturing engineering from product development through launch.
- Develop and implement manufacturing technologies for new products.
- Apply DFM principles; lead design, manufacturing, readiness, supply chain, and design transfer reviews.
- Integrate new products into manufacturing; manage phase-in/phase-out aligned with design, regulatory, and clinical needs.
- Assess, develop, qualify, and validate supplier capability, capacity, and risk.
- Lead supplier validations, initial builds, commercialization, inspections, fixtures, and test method validation.
- Define supplier qualification requirements for OEMs, contract manufacturers, and custom materials.
- Audit suppliers for technical capability and quality system compliance; ensure Tier 1–Tier 2 alignment.
- Provide technical input to strategic sourcing, supplier selection, part qualification, specs, and implementation.
- Drive product, process, cost, lean manufacturing, and waste reduction improvements with suppliers.
- Lead cross-functional issue resolution with urgency; manage milestones and timelines.
- Perform design and drawing reviews; support continuous improvement using structured problem-solving tools.
- BS in Engineering/Scientific field with 4+ years experience or MS with 3+ years experience.
- On-site work required; up to 20% domestic/international travel.
- Experience with SPC, Six Sigma, DMAIC, and quality tools.
- Experience in catheter manufacturing and cardiovascular, endovascular, minimally invasive, or implantable medical devices.
- CAD experience (ProE and/or Solid Works).
- Strong analytical, problem-solving, technical writing, project management, and communication skills.
- Ability to work independently and cross-functionally with strong interpersonal and conflict-resolution skills.
- Mid-Senior level
- Contract
- Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research
Position Requirements
10+ Years
work experience
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