Senior NPI Engineer - MedTech Shockwave Innovator

Johnson & Johnson Innovative Medicine; Santa Clara (CA); On-site; USD 106,000 - 170,000; Full time

Benefits offered by this job

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year

Holiday pay 13 days per calendar year

Work, Personal and Family Time - up to

Parental Leave – 480 hours

Bereavement Leave – 240 hours

Caregiver Leave – 80 hours

Volunteer Leave – 32 hours

Military Spouse Time-Off – 80 hours

Job summary

Johnson & Johnson is hiring a Senior NPI Engineer for Shockwave Medical in Santa Clara, CA, to design, develop, test, and implement processes and fixtures across the product lifecycle. The role collaborates with R&D, QA, RA, and Production to support manufacturing readiness, process validation, and continuous improvement, applying Lean and Six Sigma.

Candidates should have a BS in Mechanical or Biomedical Engineering with 5+ years in medical devices, knowledge of FDA/ISO, SolidWorks, ERP/MES,

Qualifications

• BS in Mechanical or Biomedical Engineering.
• Min 5 years in a medical device environment.
• Knowledge of FDA, ISO, MDR/QA systems.
• Lean and Six Sigma concepts experience.
• IQ-OQ-PQ validation experience.
• Solid understanding of statistics (Cpk, DOE).

Responsibilities

• Design, develop, test, document, and implement processes, tooling and fixtures across the product lifecycle.
• Collaborate with R&D, QA, RA and Production to address non-conformances.
• Analyze process performance for new and existing products.
• Develop documentation for design control and manufacturing procedures.
• Lead and participate in DMAIC and continuous improvement projects.

Skills

DMAIC

Lean Six Sigma

Statistical Analysis

Project Management

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP (Oracle)

MES (Oracle)

Job description

Johnson & Johnson is hiring a Senior NPI Engineer for Shockwave Medical in Santa Clara, CA, to design, develop, test, and implement processes and fixtures across the product lifecycle. The role collaborates with R&D, QA, RA, and Production to support manufacturing readiness, process validation, and continuous improvement, applying Lean and Six Sigma.

Candidates should have a BS in Mechanical or Biomedical Engineering with 5+ years in medical devices, knowledge of FDA/ISO, SolidWorks, ERP/MES,