Staff NPI Engineer – Cardio Medical Devices

6947-SHOCKWAVE MEDICAL INC. Legal Entity; Santa Clara (CA); On-site; USD 129,000 - 208,000; Full time

Benefits offered by this job

Long-term incentive

Competitive benefits

Job summary

Johnson & Johnson is hiring a Staff NPI Engineer in Santa Clara, CA to drive process development for cardiovascular and peripheral devices. You will partner with R&D, Operations, Regulatory, and Quality to move designs from development into production while upholding quality standards.

The role requires 8+ years in engineering (or 5+ with an advanced degree), medical device exposure, and expertise in DFMA, validation (IQ-OQ-PQ), and SolidWorks.

Qualifications

• Engineering background with medical device industry experience preferred.
• Familiarity with QSRs/FDA/ISO MDR regulatory frameworks.
• Strong problem solving and statistical skills.

Responsibilities

• Collaborate with R&D, QA, and Production to design and validate processes.
• Develop tissue/plastic catheter-related manufacturing steps and fixtures.
• Lead DFMA and design reviews for new and existing products.
• Document protocols, test methods, and validation activities.

Skills

Lean Six Sigma

DOE & Gage R&R

SolidWorks

ERP/MES systems

IQ-OQ-PQ validation

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree (recommended)

Tools

SolidWorks

Oracle ERP/MES

Job description

Johnson & Johnson is hiring a Staff NPI Engineer in Santa Clara, CA to drive process development for cardiovascular and peripheral devices. You will partner with R&D, Operations, Regulatory, and Quality to move designs from development into production while upholding quality standards.

The role requires 8+ years in engineering (or 5+ with an advanced degree), medical device exposure, and expertise in DFMA, validation (IQ-OQ-PQ), and SolidWorks.