Senior MedTech NPI Engineer for Cardiovascular Devices

Biopharma Careers; Santa Clara (CA); On-site; USD 106,000 - 170,000; Full time

Benefits offered by this job

Vacation 120 hours per year

Sick time and holidays

Parental Leave

Job summary

Johnson & Johnson is seeking a Senior NPI Engineer to design, develop and launch processes, tooling, and fixtures for intravascular devices in Santa Clara, CA. You will work with cross‑functional teams to ensure quality and compliance throughout the product lifecycle.

The role emphasizes Lean/Six Sigma, process validation, and scalable manufacturing, with strong emphasis on collaboration with R&D, QA and operations in a fast-paced environment.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering required.
• Experience with Quality System requirements (FDA/ISO/MDR) preferred.
• Lean and Six Sigma knowledge a plus.

Responsibilities

• Design, develop, test, document and implement processes, tooling, and fixtures for product lifecycle.
• Collaborate with R&D, QA, RA and Production to support manufacturing operations.
• Lead or participate in problem solving using DMAIC methodology.
• Develop and maintain design control documentation, BOMs, and manufacturing procedures.
• Prototype designs and validate processes for scale-up and commercialization.
• Perform process verification and validation testing and cost analyses.

Skills

Analytical Reasoning

Biological Engineering

Data Savvy

Project Schedule

Prototyping

Research and Development

SAP Product Lifecycle Management

Technologically Savvy

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP/MES

Job description

Johnson & Johnson is seeking a Senior NPI Engineer to design, develop and launch processes, tooling, and fixtures for intravascular devices in Santa Clara, CA. You will work with cross‑functional teams to ensure quality and compliance throughout the product lifecycle.

The role emphasizes Lean/Six Sigma, process validation, and scalable manufacturing, with strong emphasis on collaboration with R&D, QA and operations in a fast-paced environment.