Senior NPI Engineer, MedTech Device Manufacturing

Biopharma Asia; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Retirement plan

Long‑term incentive program

Comprehensive leave policy

Job summary

Johnson & Johnson in Santa Clara, CA is hiring a Senior NPI Engineer to design, develop, validate, and implement manufacturing processes and fixtures across the product lifecycle. You will work with Production, Quality, and R&D to ensure timely launches and compliant documentation.

The role requires 5+ years in engineering (or 3+ with a MS), strong Lean/Six Sigma experience, and proficiency in SolidWorks. Knowledge of FDA/ISO MDR and ERP/MES systems is essential.

Qualifications

• Bachelor’s or Master’s in Mechanical or Biomedical Engineering with 3–5+ years in medical devices.
• Knowledge of QSRs, FDA, ISO, MDR and relevant regulations.
• Lean & Six Sigma; proficient in validation IQ-OQ-PQ.
• Proficiency in SolidWorks for drawings.
• Experience with ERP and MES systems (Oracle preferred).

Responsibilities

• Design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Collaborate with cross‑functional teams to ensure timely product launches.
• Create and maintain design controls and product documentation per FDA/ISO requirements.
• Lead or support process verification and validation protocols and reports.
• Drive continuous improvement using DMAIC or similar methodologies.

Skills

Analytical reasoning

Problem solving

Statistical methods

SolidWorks

ERP/MES (Oracle)

SAP PLM

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Master’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP

MES (Oracle preferred)

SAP Product Lifecycle Management

Job description

Johnson & Johnson in Santa Clara, CA is hiring a Senior NPI Engineer to design, develop, validate, and implement manufacturing processes and fixtures across the product lifecycle. You will work with Production, Quality, and R&D to ensure timely launches and compliant documentation.

The role requires 5+ years in engineering (or 3+ with a MS), strong Lean/Six Sigma experience, and proficiency in SolidWorks. Knowledge of FDA/ISO MDR and ERP/MES systems is essential.