Senior NPI Engineer: Medical Device Process Innovation

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 106,000 - 170,200; Full time

Job summary

Johnson & Johnson is hiring for a Senior NPI Engineer – Shockwave Medical in Santa Clara, CA. You will design and implement manufacturing processes and fixtures, collaborating with R&D, QA and Production to ensure new products meet stringent quality standards.

Requirements include a Bachelor’s degree in Mechanical or Biomedical Engineering and at least 5 years in a medical device environment, with experience in Lean/Six Sigma, IQ-OQ-PQ validation, and SolidWorks.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering required.
• Minimum 5 years of experience in a medical device environment.
• Knowledge of QSRs, FDA, ISO, MDR and related quality systems.
• Lean and Six Sigma concepts understood; DMAIC experience a plus.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• SolidWorks drawings creation/maintenance; ERP/MES experience.

Responsibilities

• Design, develop, test, document and implement processes, tooling, and fixtures across the product lifecycle.
• Collaborate with R&D, QA, RA and Production to address issues and support manufacturing scopes.
• Develop protocols and verification/validation testing for new products.
• Lead continuous improvement projects and apply Lean manufacturing principles to reduce waste.

Skills

Analytical reasoning

SAP Product Lifecycle Management

Prototyping

Project scheduling

Data savvy

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP and MES (Oracle)

SAP Product Lifecycle Management (PLM)

Job description

Johnson & Johnson is hiring for a Senior NPI Engineer – Shockwave Medical in Santa Clara, CA. You will design and implement manufacturing processes and fixtures, collaborating with R&D, QA and Production to ensure new products meet stringent quality standards.

Requirements include a Bachelor’s degree in Mechanical or Biomedical Engineering and at least 5 years in a medical device environment, with experience in Lean/Six Sigma, IQ-OQ-PQ validation, and SolidWorks.