Manufacturing Engineer II – Shockwave

About the role

The Manufacturing Engineer II supports production of Shockwave Medical devices, designing and implementing processes, tooling, and fixtures for commercial products. The role also sustains line activities, resolves raw material, process, and equipment issues, and contributes to new product introductions.

Key responsibilities

• Collaborate with Production to resolve product, process, and equipment problems.
• Lead process, tooling, equipment, and cost‑reduction improvement projects.
• Perform functional and destructive testing, document results, and conduct statistical analysis using Minitab or Excel.
• Support new product introductions, scaling, stabilizing, and site transfers.
• Develop and maintain FMEAs, Manufacturing Process Instructions, and Device Master Record documents.
• Create and transfer Bill of Materials and Lot History Records into electronic systems.
• Assist in resolving quality events (NCR, CAPA, audit findings) and maintain quality system requirements.
• Create label files and execute process validation protocols and reports.

Required profile

• Bachelor’s degree in engineering.
• 3‑5 years of experience in a medical device environment.
• Knowledge of QSR, FDA, ISO, MDD/MDR regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with medical device validation (IQ‑OQ‑PQ).
• Ability to work in a fast‑paced environment and manage multiple priorities.

Required skills

• SolidWorks for creating and maintaining drawings.
• Minitab and Excel for statistical analysis.
• MES and Oracle ERP systems.
• Lean and Six Sigma methodologies.
• Process FMEA development.
• Validation protocols (IQ‑OQ‑PQ).

What we offer

• Base salary $73,000 – $117,300 annually.
• Performance‑based annual bonus.
• Comprehensive benefits including medical, dental, vision, life insurance, disability, and legal insurance.
• Retirement plans (pension and 401(k)).
• Paid time off: vacation, sick leave, holidays, and personal/family time.