Staff Manufacturing Engineer, Medical Devices & IVL

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

Job summary

Johnson & Johnson is seeking a Staff Manufacturing Engineer for Shockwave Medical in Santa Clara, CA. You will design, develop, test, document and implement manufacturing processes, tooling and fixtures across the product lifecycle to support launches.

Collaborate with R&D, QA and Production to drive process improvements, perform PFMEAs, support design control and technology transfers, while applying Lean, statistics and DOE in a fast‑paced medical device environment.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• 8+ years of medical device experience, or 6+ years with a Master’s degree.
• Knowledge of QSRs, FDA, ISO, MDD and applicable regulations.
• Experience with Process Validations (IQ, OQ, PQ), 6S, Lean Manufacturing.
• Experience applying statistics, DOE and capability studies (Cpk).
• Strong written and verbal communication; ability to present data.

Responsibilities

• Design, develop, test, document and implement processes, tooling and fixtures.
• Lead tolerance analyses for components, materials and packaging.
• Develop and maintain PFMEAs and design/control documentation.
• Support process development, transfer and qualification of product lines.
• Lead process and product improvement projects with cross‑functional teams.
• Apply DMAIC methodology to solve problems and improve efficiency.

Skills

Statistical Analysis

Communication Skills

Lean Manufacturing

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Master's Degree (optional with 6+ years experience)

Tools

Solidworks

Minitab

DOE

Cpk Analysis

Job description

Johnson & Johnson is seeking a Staff Manufacturing Engineer for Shockwave Medical in Santa Clara, CA. You will design, develop, test, document and implement manufacturing processes, tooling and fixtures across the product lifecycle to support launches.

Collaborate with R&D, QA and Production to drive process improvements, perform PFMEAs, support design control and technology transfers, while applying Lean, statistics and DOE in a fast‑paced medical device environment.