Staff Manufacturing Engineer – Shockwave

About the role

Johnson & Johnson is seeking a Staff Manufacturing Engineer for its Shockwave Medical team in Santa Clara, CA. The role focuses on designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle to support manufacturing operations and product launches.

Key responsibilities

• Collaborate with R&D, QA, and Production to design and implement processes, tooling, and fixtures.
• Collect and analyze process performance data, conduct tolerance analysis, and lead pFMEA development.
• Develop and maintain design control documentation, manufacturing procedures, and lot history records.
• Lead DMAIC‑based problem‑solving and process improvement projects.
• Perform productivity and costing analyses, identify cost‑reduction opportunities, and support supplier selection.

Required profile

• Bachelor’s in Mechanical or Biomedical Engineering (Master’s preferred) with at least 8 years of medical‑device (or equivalent) experience.
• Strong knowledge of QSR, FDA, ISO, MDD regulations and process validation (IQ, OQ, PQ).
• Proven ability to apply statistics, run capability studies (Cpk) and design of experiments.
• Excellent written and verbal communication skills and ability to work in a fast‑paced, multi‑priority environment.

Required skills

• SolidWorks
• Minitab or similar statistical software
• Design of Experiments (DOE) methodology
• Capability analysis (Cpk) and tolerance analysis

What we offer

• Base salary range $105,000 – $169,050 annually, performance‑based bonus.
• Comprehensive benefits including medical, dental, vision, life insurance, disability, legal insurance, 401(k) retirement plan.
• Generous paid time off: up to 120 vacation hours, sick leave, holidays, and personal/family time.