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