Job Description

Senior Engineer – Supplier Development (18-Month Contract) - Possible Extension

Location: Onsite in Irvine, CA

A leading medical device company is seeking a Senior Supplier Development Engineer to support the development of implantable devices and delivery systems for cardiovascular applications. This role is embedded within the Advanced Technology team and will provide end-to-end manufacturing engineering support, focusing on new product development (NPD) and supplier collaboration. The ideal candidate will bring a strong mix of technical expertise, cross-functional teamwork, and experience in design for manufacturability (DFM).

Key Responsibilities:

• Lead manufacturing and supplier engineering activities from concept through launch of novel medical devices.
• Provide technical input on sourcing projects including specification review, part qualification, supplier validation, and transition to production.
• Collaborate with suppliers to identify and implement product and process improvements.
• Support DFM efforts, including drawing reviews and risk-based assessments.
• Conduct supplier validations, test method validation, and coordinate inspection fixture design.
• Participate in root cause investigations and implement CAPAs as needed.
• Manage project timelines and cross-functional alignment to ensure successful commercialization.
• Evaluate and audit supplier capabilities, ensuring Tier 1 and Tier 2 readiness and alignment.
• Contribute to process optimization and lean manufacturing initiatives at supplier sites.
• Coordinate activities between R&D, quality, design assurance, and external vendors.

Required Qualifications:

• Bachelor’s degree in Engineering or a related technical discipline and 4+ years of relevant experience
• OR
• Master’s degree in Engineering with 3+ years of experience
• Demonstrated experience in supplier development, manufacturing engineering, or new product development
• Ability to travel up to 20% (domestic/international)
• On-site presence in Irvine, CA required approximately 80% of the time

Preferred Qualifications:

• Prior experience with catheter manufacturing or cardiovascular devices
• Solid understanding of statistical tools (e.g., SPC, Six Sigma, DMAIC)
• Experience with SolidWorks or similar CAD software
• Familiarity with internal manufacturing processes and process capability improvements
• Root Cause Analysis and CAPA implementation experience
• Excellent written and verbal communication skills
• Team-oriented with strong interpersonal and project management capabilities

Work Environment and Additional Notes:

• Role supports development of two innovative expandable sheath devices
• Expected to work closely with cross-functional partners across R&D, Design Assurance, and Product Development
• Quarterly international travel may be required (e.g., to Europe)
• Interview process includes a single panel with stakeholders from R&D and Engineering

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