Sr. Engineer

Senior Supplier Development Engineer

Location: Irvine, CA

Schedule: Standard Office Hours

Duration: 18-Month Contract

We are seeking a Senior Supplier Development Engineer to join our Advanced Technology Supplier Development Engineering team. In this role, you'll provide key manufacturing engineering support for the design and development of implantable devices and delivery systems used to treat cardiovascular disease.

Key Responsibilities:

Lead engineering activities throughout the product development lifecycle-from concept to product launch

Develop and implement manufacturing technologies to meet evolving product requirements

Apply Design for Manufacturability (DFM) principles to improve product designs and ensure they are optimized for production

Conduct DFM reviews to ensure manufacturability is integrated early in the design process

Evaluate supplier capabilities and drive improvements in part quality and consistency

Partner with suppliers to meet technical specifications and quality expectations

Lead supplier validation, support early builds, and ensure smooth product commercialization

Manage product transitions (phase-in/phase-out) based on design, regulatory, and clinical requirements

Support manufacturing readiness and design transfer to production

Impactful Contributions:

Provide technical guidance for strategic sourcing-review supplier capabilities, define qualification plans, and oversee part transitions into manufacturing

Engage in technical discussions with suppliers to drive product and process improvements

Review and provide input on component designs and drawings to confirm manufacturing feasibility

Define supplier qualification requirements for OEMs, contract manufacturers, and custom materials

Lead validation of supplier test methods, including fixture design for inspection

Address quality issues quickly and escalate appropriately to maintain project timelines

Ensure suppliers at all levels (Tier 1 and Tier 2) meet performance and capability expectations

Facilitate alignment among internal teams and suppliers to resolve open issues

Work with suppliers to optimize manufacturing processes, reduce costs, and eliminate waste

Develop and track project timelines to meet development and launch milestones

Perform supplier risk and capacity assessments to ensure timely and successful commercialization

Conduct technical and quality audits of suppliers

Support additional responsibilities as assigned

Basic Qualifications:

Bachelor's degree in Engineering or a scientific field with 4+ years of industry or combined academic/industry experience, or

Master's degree in Engineering or a scientific field with 3+ years of experience

Ability to work onsite and travel up to 20% (domestic/international)

Preferred Qualifications:

Proficiency with statistical tools (e.g., SPC, Six Sigma, DMAIC)

Experience with catheter manufacturing or cardiovascular/endovascular device development

CAD experience using ProE or SolidWorks

Strong analytical, problem-solving, and technical writing skills

Solid project management experience

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