Sr. NPI Engineer - Johnson and Johnson MedTech, Circulatory Restoration

• Job Function: R&D Product Development
• Job Sub Function:
  Biomedical Engineering
• Job Category:
  Scientific/Technology
• All Job Posting Locations:
  Santa Clara, California, United States of America

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow,and profoundly impact health for humanity.

Learn more at

Cardiovascular Solutions from Johnson & Johnson Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke.

For more information on circulatory restoration, visit our website.

• Collaborate with R&D, Quality, Regulatory, and Production teams to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures.
• Support Quality in addressing and resolving non-conformances.
• Collect and analyze process performance data and capabilities for both new and existing products.
• Identify process requirements and support operations by designing, developing, and implementing equipment and fixtures for process development and manufacturing.
• Develop and maintain documentation in compliance with design control, product configuration, manufacturing procedures, and lot history records (e.g., Bills of Materials, MPIs, LHRs), in alignment with FDA, ISO, MDR, and other applicable Quality System requirements
• 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 point of contact for manufacturing-related project activities, including responding to internal and external requests and supporting pilot manufacturing.
• Stay current with competitive technologies and advancements in medical, technical, and biomedical fields related to the company’s products.
• Lead or participate in product and process engineering problem-solving using DMAIC or similar methodologies.
• Drive or support continuous improvement projects for processes and products, working closely with development engineers and technicians.
• Apply Lean manufacturing principles to reduce waste and improve productivity in production processes.
• Support Procurement and R&D with supplier selection and process development.
• Conduct productivity and cost analyses, including calculating direct labor and material costs for new and existing products, and identifying cost reduction opportunities.
• Perform other duties as assigned.

This job description is not intended to be an exhaustive list of all responsibilities, duties, and skills required.

• Bachelor’s degree in Mechanical or Biomedical Engineering with 5+ years’ of engineering experience, or a…