Senior NPI Engineer – Shockwave Medical

About the role

The Senior NPI Engineer will design, develop, test, document, and implement processes, tooling, and fixtures for Shockwave Medical’s intravascular lithotripsy devices throughout the product lifecycle, from concept to production.

Key responsibilities

• Collaborate with R&D, QA, RA, and Production to create and validate manufacturing processes and tooling.
• Collect and analyze process performance data, develop process capability studies, and support pilot manufacturing.
• Maintain design‑control documentation, lot history records, and ensure compliance with FDA, ISO, MDR and other quality system requirements.
• Lead DMAIC problem‑solving and continuous‑improvement projects, applying Lean principles to reduce waste.
• Assist procurement and R&D with supplier selection, cost analysis, and cost‑reduction initiatives.

Required profile

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum 5 years of experience in a medical‑device environment.
• Knowledge of QSR, FDA, ISO, MDD/MDR regulations and validation (IQ‑OQ‑PQ).
• Ability to work in a Class 8 cleanroom and lift up to 25 lb.

Required skills

• SolidWorks for creating and maintaining drawings.
• Lean manufacturing and Six Sigma methodologies.
• Statistical tools: Cpk, hypothesis testing, DOE, Gage R&R.
• ERP/MES systems (Oracle preferred).
• Understanding of disposable peripheral and coronary device design.