Senior NPI Engineer, MedTech & Cardio Devices

Quest Oracle Community; Santa Clara, Northern (CA, KY); Hybrid; USD 106,000 - 170,000; Full time

Job summary

Johnson & Johnson seeks a Senior NPI Engineer for the Shockwave Medical program in Santa Clara, CA. You will design, develop, test and implement processes, tooling and fixtures across the product lifecycle, collaborating with R&D, QA, RA and Production to support new product introductions and manufacturing readiness.

The role requires medical device experience, Lean Six Sigma expertise, and strong documentation practices to ensure FDA/ISO compliance and successful launches.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• Min 5 years of experience in a medical device environment.
• Knowledge of FDA, ISO, MDR and other Quality System requirements.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Ability to create and maintain Drawings in SolidWorks; ERP/MES experience (Oracle preferred).

Responsibilities

• Design, develop, test, document and implement processes, tooling, and fixtures.
• Support quality to address non-conformances.
• Collect data and analyze process performance for new and existing products.
• Identify process requirements and support equipment/fixturing development for manufacturing.
• Develop and maintain design control documentation and manufacturing procedures.
• Lead DMAIC-based process and product improvement projects.
• Apply Lean manufacturing principles to reduce waste and increase productivity.
• Collaborate with Procurement and R&D on supplier selection and process development.

Skills

DMAIC

Lean Six Sigma

Statistics

SolidWorks

ERP/MES (Oracle)

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP/MES (Oracle)

Job description

Johnson & Johnson seeks a Senior NPI Engineer for the Shockwave Medical program in Santa Clara, CA. You will design, develop, test and implement processes, tooling and fixtures across the product lifecycle, collaborating with R&D, QA, RA and Production to support new product introductions and manufacturing readiness.

The role requires medical device experience, Lean Six Sigma expertise, and strong documentation practices to ensure FDA/ISO compliance and successful launches.