NPI Engineer II — MedTech Process Innovator

Quest Oracle Community; Santa Clara, Northern (CA, KY); Hybrid; USD 87,000 - 140,000; Full time

Benefits offered by this job

Pension plan

401(k)

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is hiring an NPI Engineer II in Santa Clara, CA to advance process development for peripheral, coronary, and heart valve devices. You will oversee pilot manufacturing, support transitions to production, and collaborate with R&D, operations, regulatory, and quality teams to bring innovations to market.

The role focuses on process validation, sustaining support, and transfer activities across cross-functional teams in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in Mechanical or Biomedical Engineering.
• Min 3 years in medical device environment.
• Knowledge of QSRs, FDA, ISO, MDR requirements.
• Lean and Six Sigma concepts.
• Experience with IQ-OQ-PQ validation.
• Solid understanding of statistics (Cpk, DOE, Gage R&R).

Responsibilities

• Collaborate with Production to provide sustaining support.
• Identify and participate in process improvement projects.
• Perform functional and destructive testing and analyze results.
• Support new product introductions including scaling and transfer.
• Maintain process FMEAs, MPIs, and DMR documents.
• Create and transfer BOMs and LHRs into Item Structures and LHRs.
• Support quality events and maintain Quality System requirements.
• Create and release label files.
• Execute process validation protocols and reports.

Skills

Lean Six Sigma

Cross-functional teamwork

Statistical analysis

Communication skills

Education

Bachelor's degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

Oracle ERP/MES

Job description

Johnson & Johnson is hiring an NPI Engineer II in Santa Clara, CA to advance process development for peripheral, coronary, and heart valve devices. You will oversee pilot manufacturing, support transitions to production, and collaborate with R&D, operations, regulatory, and quality teams to bring innovations to market.

The role focuses on process validation, sustaining support, and transfer activities across cross-functional teams in a fast-paced medical device environment.