NPI Engineer II - MedTech for Cardio Devices

Johnson & Johnson Innovation; Santa Clara (CA); On-site; USD 87,000 - 140,000; Full time

Job summary

Johnson & Johnson is hiring for an NPI Engineer II – Shockwave Medical to join our Santa Clara, CA team. You will lead process development for the engineering group, oversee pilot manufacturing/testing, and help transfer products from development into production.

The role requires a Bachelor's degree in Mechanical or Biomedical Engineering and at least 3 years of medical device experience, with knowledge of QSRs/ FDA/ISO and Lean Six Sigma.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering with relevant coursework.
• 3+ years of experience in a medical device environment.
• Knowledge of QSRs, FDA, ISO, MDD, MDR and related regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Statistics knowledge: Cpk, Hypothesis Testing, DOE, Gage R&R a plus.
• Ability to create and maintain Drawings in SolidWorks.
• Experience with ERP and MES (Oracle preferred).
• Knowledge of disposable peripheral and coronary device design, material selection, and testing preferred.

Responsibilities

• Actively collaborate with Production to provide sustaining support for product/process problems.
• Identify and participate in process/product improvement projects.
• Perform functional and destructive testing and analyze results.
• Participate in new product introduction and transfer to site.
• Maintain process FMEAs, MPIs, and DMR documents.
• Create and transfer BOMs and LHRs.
• Support Quality System activities (NCR, CAPA, Audit findings).
• Create and release label files for product labeling.
• Develop and execute process validation protocols and reports.
• Other duties as assigned.

Skills

Lean Six Sigma

Statistics

Team collaboration

Process development

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP

MES

Oracle

Job description

Johnson & Johnson is hiring for an NPI Engineer II – Shockwave Medical to join our Santa Clara, CA team. You will lead process development for the engineering group, oversee pilot manufacturing/testing, and help transfer products from development into production.

The role requires a Bachelor's degree in Mechanical or Biomedical Engineering and at least 3 years of medical device experience, with knowledge of QSRs/ FDA/ISO and Lean Six Sigma.