Senior Manufacturing Mechanical Engineer – Shockwave

About the role

Johnson & Johnson is seeking a Senior Manufacturing Mechanical Engineer to support Shockwave Medical products in Santa Clara, CA. The role focuses on technical support for contract manufacturers and suppliers, driving validation, troubleshooting, and continuous improvement of manufacturing lines.

Key responsibilities

• Act as primary technical liaison with contract manufacturers and external partners for process transfer and scale‑up.
• Prepare and execute validation protocols, generate PFMEA documentation, and manage engineering change orders.
• Lead cost‑reduction and process‑improvement projects using lean tools, 6S, JIT, and Kanban.
• Develop manufacturing instructions, inspection plans, and tooling for production.
• Support suppliers in failure investigations, root‑cause analysis, and product reliability improvements.

Required profile

• Bachelor’s degree in Mechanical Engineering or related field.
• Minimum 5 years of experience in process/manufacturing development and launch of high‑volume medical devices.
• Strong analytical skills with experience in statistical analysis, DOE, and Gage R&R.
• Excellent communication and organizational abilities, able to work with cross‑functional teams.

Required skills

• SolidWorks (preferred)
• Lean manufacturing and Design for Manufacturability
• PFMEA creation and risk management
• Statistical analysis, hypothesis testing, Cpk
• Design of Experiments (DOE)
• Gage R&R
• 3D printing, UL impact testing, material selection
• Project planning tools (Gantt charts, Smartsheet)

What we offer

• Base salary $89,000 – $142,600 annually
• Performance‑based annual bonus
• Medical, dental, vision, life, disability, and legal insurance
• 401(k) retirement plan
• Generous paid time off: up to 120 vacation hours, sick leave, holidays and floating days