Staff NPI Engineer – Medical Devices (Shockwave)

Johnson & Johnson Innovation; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Annual performance bonus

Job summary

Johnson & Johnson is seeking a Staff NPI Engineer – Shockwave Medical to join the Santa Clara team. The role focuses on developing and validating new catheter manufacturing processes, overseeing pilot manufacturing, and guiding products from development into full production.

The position requires extensive engineering experience in the medical device field, knowledge of DFMEA/DOE, and collaboration with R&D, Operations, Regulatory, and Quality teams to ensure compliant, scalable solutions.

Qualifications

• Bachelor’s in Mechanical or Biomedical Engineering with 8+ years of engineering experience, or Master’s with 5+ years.
• Experience in medical device industry and FDA/QSR/regulatory experience.
• Knowledge of Lean Six Sigma principles and design controls (IQ-OQ-PQ).

Responsibilities

• Design, develop, test, document, and implement processes, tooling, and fixtures for catheter manufacturing.
• Lead DFMEA and process validation activities.
• Develop and maintain technical documentation, drawings, and specifications.
• Support pilot manufacturing and product transfers from concept to commercialization.
• Collaborate across R&D, Operations, Regulatory, and Quality teams.

Skills

Mechanical Design

Biomedical Engineering

Lean Six Sigma

Statistical Methods

Communication

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Master’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP / MES

Job description

Johnson & Johnson is seeking a Staff NPI Engineer – Shockwave Medical to join the Santa Clara team. The role focuses on developing and validating new catheter manufacturing processes, overseeing pilot manufacturing, and guiding products from development into full production.

The position requires extensive engineering experience in the medical device field, knowledge of DFMEA/DOE, and collaboration with R&D, Operations, Regulatory, and Quality teams to ensure compliant, scalable solutions.