Senior NPI Engineer - MedTech Device Innovation

Johnson & Johnson Innovation

Santa Clara (CA)

On-site

USD 106,000 - 170,000

Full time

14 days+

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Job summary

Johnson & Johnson Innovation in Santa Clara, CA is seeking a Senior NPI Engineer to design and implement processes and fixtures for medical device manufacturing from design through production. You will partner with R&D, QA and Production to ensure robust process development and documentation.

The role requires 5+ years in medical devices, Lean Six Sigma expertise, and experience with IQ-OQ-PQ validations, SolidWorks, and ERP/MES (Oracle).

Qualifications

Bachelor’s degree in Mechanical or Biomedical Engineering.
Min 5 years of experience in a medical device environment.
Knowledge of and compliance with applicable Quality System requirements (QSRs, FDA, ISO, MDR).
Understanding of Lean and Six Sigma concepts.
Experience with Validation of Medical Devices (IQ-OQ-PQ).
Ability to create and maintain Drawings in SolidWorks.
Experience with ERP and MES (Oracle).
Knowledge of disposable peripheral and coronary device design is a plus.
Experience in early-stage catheter-based cardiovascular devices is a plus.

Responsibilities

Collaborate with R&D, QA, RA and Production to design, test, document and implement processes, tooling and fixtures.
Support Quality to address non-conformances.
Collect data and analyze process performance for new and existing products.
Develop and maintain design control documentation and manufacturing procedures.
Lead process development and pilot manufacturing activities.
Apply Lean manufacturing principles to reduce waste and increase productivity.