Staff Manufacturing Engineer, IVL Shockwave

J&J Family of Companies; Santa Clara (CA); On-site; USD 105,000 - 169,000; Full time

Job summary

Johnson & Johnson in Santa Clara, CA is seeking a Staff Manufacturing Engineer, Shockwave Medical to join our team. The role focuses on designing, validating, and implementing manufacturing processes and tooling across the product lifecycle for advanced cardiovascular solutions.

This position requires collaboration with R&D, QA and Production, performing tolerance analyses, process validations, and driving cost-effective improvements in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering required, with relevant experience in medical devices preferred.
• Experience with Process Validations (IQ, OQ, PQ), 6S and Lean Manufacturing.
• Strong written and verbal communication skills and ability to present findings.

Responsibilities

• Design, develop, test, document and implement processes, tooling and fixtures for product lifecycle.
• Collect data and analyze process performance for new and existing products.
• Perform tolerance analysis for components, materials, packaging, and supplies.
• Lead PFMEAs (process FMEAs) and ensure design control documentation is maintained.
• Prepare user requirements and technical specifications.
• Support operations with equipment and fixturing for development and manufacturing.
• Develop and maintain manufacturing procedures and lot history records.
• Lead continuous improvement projects using DMAIC methodology.
• Collaborate with R&D, QA and Production on process development and validation.

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Minitab

Job description

Johnson & Johnson in Santa Clara, CA is seeking a Staff Manufacturing Engineer, Shockwave Medical to join our team. The role focuses on designing, validating, and implementing manufacturing processes and tooling across the product lifecycle for advanced cardiovascular solutions.

This position requires collaboration with R&D, QA and Production, performing tolerance analyses, process validations, and driving cost-effective improvements in a fast-paced medical device environment.