NPI Engineer II – Medical Device Development

About the role

The NPI Engineer II will develop and transition innovative cardiovascular medical devices from pilot manufacturing to full production, supporting the Shockwave Medical portfolio.

Key responsibilities

• Collaborate with Production to resolve product, process, and equipment issues.
• Lead process optimization, tooling, equipment, and cost‑reduction projects.
• Coordinate functional and destructive testing, document results, and perform statistical analysis.
• Support new product introduction, scaling, stabilizing, and site transfers.
• Develop and maintain FMEAs, Manufacturing Process Instructions, and Device Master Record documents.
• Maintain Bill of Materials, Lot History Records, and label files.
• Assist in quality event resolution (NCR, CAPA, audit findings) and ensure compliance with QSR, FDA, ISO, MDD/MDR regulations.

Required profile

• Bachelor’s degree in Mechanical or Biomedical Engineering.
• Minimum 3 years of experience in a medical‑device environment.
• Knowledge of Lean and Six Sigma concepts and validation protocols (IQ‑OQ‑PQ).
• Ability to work in a fast‑paced, cross‑functional team and lift up to 25 lb.
• Willingness to work in an air‑conditioned Class 8 cleanroom.

Required skills

• SolidWorks for creating and maintaining drawings.
• Minitab or Excel for statistical analysis.
• Oracle ERP and MES systems.
• Lean Six Sigma methodology.
• Medical‑device validation (IQ‑OQ‑PQ) and quality system compliance.
• Statistical tools (Cpk, hypothesis testing, DOE, Gage R&R).