Senior NPI Engineer, Medical Devices - Process Development

Johnson & Johnson Co.; Santa Clara (CA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

401(k) plan

Pension

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is hiring a Sr. NPI Engineer for our Santa Clara, CA team.

The role collaborates with R&D, Quality, Regulatory and Production to design, test and implement manufacturing processes, tooling and fixtures, while addressing non-conformances and analyzing process data for both new and existing products. The position requires mechanical/biomedical engineering credentials with 5+ years experience (3 years with Master’s) in the medical device field, plus knowledge of QSR/FDA/ISO/MDR,

Qualifications

• Engineering experience in the medical device industry preferred.
• Knowledge of Quality System requirements (QSRs, FDA, ISO, MDR).
• Understanding of Lean and Six Sigma principles.
• Experience with IQ-OQ-PQ validation.

Responsibilities

• Collaborate with R&D, Quality, Regulatory and Production to design, develop, test and implement manufacturing processes, tooling and fixtures.
• Support Quality in addressing non-conformances.
• Collect and analyze process performance data and capabilities for new and existing products.
• Identify process requirements and design equipment/fixtures for process development and manufacturing.
• Develop and maintain design/control documentation in line with FDA/ISO/MDR and quality systems.
• Prototype and develop designs, processes and test methods to support new product development and scale-up for commercialization.
• Create and execute process verification and validation protocols and reports.
• Represent Operations as the primary contact for manufacturing-related project activities and pilot manufacturing.
• Stay current with competitive technologies in medical/biomedical fields related to the company’s products.
• Lead or participate in product and process engineering problem-solving using DMAIC or similar methods.
• Drive continuous improvement projects with development engineers and technicians.
• Apply Lean principles to reduce waste and improve productivity.

Skills

Lean Six Sigma

Analytical thinking

Cross-functional collaboration

Prototyping

Education

Bachelor's in Mechanical or Biomedical Engineering

Master's in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP/MES Oracle

Job description

Johnson & Johnson is hiring a Sr. NPI Engineer for our Santa Clara, CA team.

The role collaborates with R&D, Quality, Regulatory and Production to design, test and implement manufacturing processes, tooling and fixtures, while addressing non-conformances and analyzing process data for both new and existing products. The position requires mechanical/biomedical engineering credentials with 5+ years experience (3 years with Master’s) in the medical device field, plus knowledge of QSR/FDA/ISO/MDR,