Staff Manufacturing Engineer, Shockwave – IVL Devices

Biopharma Asia; Santa Clara (CA); On-site; USD 105,000 - 169,000; Full time

Benefits offered by this job

Annual bonus

Medical, dental, vision insurance

401(k) retirement plan

Vacation time

Job summary

Johnson & Johnson is hiring a Staff Manufacturing Engineer, Shockwave Medical, to join our team in Santa Clara, CA. The role focuses on designing, validating, and optimizing manufacturing processes for advanced medical devices and IVL technology.

You’ll lead cross-functional efforts with R&D, QA and production, drive process improvements, and maintain design control documentation. Candidates should have extensive experience in medical devices, regulatory compliance, and data-driven problem

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum of eight years in a medical device environment or six years with a Master’s.
• Knowledge of QSRs, FDA, ISO, MDD and other regulations.
• Experience with Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing.
• Experience applying statistics and using statistical software, DOE analysis.

Responsibilities

• Collaborate with R&D, QA and Production to design, develop, test, document and implement processes, tooling and fixtures.
• Collect data and analyze process performance and capabilities for products.
• Perform tolerance analyses for components, materials and supplies.
• Lead PFMEAs for processes and ensure design control documentation is maintained.
• Prepare user requirements and design specifications for manufacturing.
• Identify process requirements and implement equipment and fixtures for development and manufacturing.

Skills

Statistical analysis

DMAIC

Lean Manufacturing

Six Sigma

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Minitab

Job description

Johnson & Johnson is hiring a Staff Manufacturing Engineer, Shockwave Medical, to join our team in Santa Clara, CA. The role focuses on designing, validating, and optimizing manufacturing processes for advanced medical devices and IVL technology.

You’ll lead cross-functional efforts with R&D, QA and production, drive process improvements, and maintain design control documentation. Candidates should have extensive experience in medical devices, regulatory compliance, and data-driven problem