Sr. Supplier Engineer - Shockwave

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Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. Supplier Engineer - Shockwave Medical to join our team located in Santa Clara, CA.

Position Overview

The Sr. Supplier Engineer is responsible for providing engineering support to Production team and external contract manufacturers..  This  position leads the development, validation, and implementation of test equipment  and fixtures for both development & commercial products. This role will troubleshoot complex and contributes to the resolution of technical challenges across  Electrical and mechanical systems, support product transfers, and collaborate cross-functionally to ensure scalable, reliable and efficient manufacturing processes.  .

Essential Job Functions

• Serve as the primary technical point of contact for  contract manufacturer and external partners, supporting the transfer and scale up of  manufacturing processes.

• Supports development transfer activities between NPD, and operations to contract manufacturer/external partner.

• Design, develop,  and maintain process risk documentation (e.g., PFMEA) to proactively identify and mitigate potential manufacturing issues.

• Prepare and execute engineering change orders and coordinate implementation activities, including training for production staff.

• Provides expertise in project planning and timeline development & management and maintain project schedules and timelines.

• Design, develop, and maintain testing fixtures, equipment, and manufacturing tools to support production and product validation.

• Collaborates with cross-functional teams to provide design for manufacturability (DFM) feedback during development phases.

• Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes.

• Develop manufacturing process documentation, including work instructions, inspection plans and lot history travelers.

• Perform cost-reduction analysis and lead initiatives to improve product quality, and process efficiency.

• Lead the design transfer of new products to production, including establishing assembly time and yield targets, training, and quality control.

• Investigate  product failures in collaboration with contract manufacturers  to determine root cause and implement corrective actions to improve product reliability and performance.

• Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, ISO standards, and internal quality systems.

• Ability to understand schematics and PCBA layout.

• Execute and document test protocols and reports for validating test equipment and medical devices.

• Troubleshoot and repa