Senior NPI Engineer — MedTech Device Launch

Johnson & Johnson Innovative Medicine; Santa Clara (CA); On-site; USD 106,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Senior NPI Engineer – Shockwave Medica l to join our Santa Clara, CA team. You will design, develop, test, and implement processes and fixtures across the product lifecycle, collaborating with R&D, QA, RA, and Production to support manufacturing and product launches.

The role requires a Mechanical or Biomedical Engineering degree, 5+ years in medical devices, knowledge of QSR/FDA/ISO, Lean and Six Sigma, and experience with SolidWorks, ERP/MES.

Qualifications

• Minimum 5 years of experience in a medical device environment.
• Knowledge of Quality System requirements such as QSRs, FDA, ISO, MDR.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Experience with SolidWorks drawings.
• Experience with ERP and MES (Oracle preferred).
• Knowledge of catheter-based cardiovascular devices is a plus.
• Ability to work in a fast-paced environment and multitask.

Responsibilities

• Design, develop, test, document, and implement processes, tooling, and fixtures across product lifecycle.
• Collaborate with R&D, QA, RA and Production to support operations and launches.
• Address non-conformances with Quality teams.
• Analyze process performance and capabilities for new products.
• Specify equipment and fixturing for development and manufacturing.
• Maintain design control documentation and product configurations.
• Prototype and validate designs for commercialization scaling.
• Lead problem solving and continuous improvement initiatives using DMAIC.
• Support pilot manufacturing and cross-functional project activities.
• Keep informed on competitive tech and biomedical trends.

Skills

Analytical Reasoning

Data Savvy

Detail-Oriented

Project Scheduling

Prototyping

Inventory Management

Biostatistics

Feasibility Studies

SAP Product Lifecycle Management

Technologically Savvy

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

ERP

MES

Oracle

Job description

Johnson & Johnson is seeking a Senior NPI Engineer – Shockwave Medica l to join our Santa Clara, CA team. You will design, develop, test, and implement processes and fixtures across the product lifecycle, collaborating with R&D, QA, RA, and Production to support manufacturing and product launches.

The role requires a Mechanical or Biomedical Engineering degree, 5+ years in medical devices, knowledge of QSR/FDA/ISO, Lean and Six Sigma, and experience with SolidWorks, ERP/MES.