Senior NPI Engineer for MedTech IVL Shockwave

Shockwave Medical; Santa Clara (CA); On-site; USD 106,000 - 170,200; Full time

Benefits offered by this job

Vacation 120 hours/yr

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is hiring a Senior NPI Engineer – Shockwave Medical in Santa Clara, CA. The role focuses on designing, developing, testing, and implementing processes, tooling, and fixtures for new product introductions in a fast-paced medical device environment.

You will work closely with R&D, QA, RA and Production teams to support manufacturing operations and product launches, applying Lean principles and validation methodologies (IQ-OQ-PQ) throughout the lifecycle.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering required.
• 5+ years of experience in a medical device environment.
• Familiar with QSRs, FDA, ISO, MDR regulatory requirements.

Responsibilities

• Design, develop, test, document and implement processes, tooling, and fixtures across product lifecycle.
• Collaborate with R&D, QA, RA and Production to support manufacturing operations.
• Lead/participate in DMAIC-based problem solving and continuous improvement.

Skills

Lean Six Sigma

Data analysis

Quality Systems

Validation IQ-OQ-PQ

Drawings SolidWorks

ERP/MES

Process development

Project coordination

Cross-functional collaboration

Statistical methods

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP

MES

Oracle

Job description

Johnson & Johnson is hiring a Senior NPI Engineer – Shockwave Medical in Santa Clara, CA. The role focuses on designing, developing, testing, and implementing processes, tooling, and fixtures for new product introductions in a fast-paced medical device environment.

You will work closely with R&D, QA, RA and Production teams to support manufacturing operations and product launches, applying Lean principles and validation methodologies (IQ-OQ-PQ) throughout the lifecycle.