Staff Mechanical Engineer, R&d

Johnson & Johnson Johnson & Johnson · Pharma · Irvine, CA +1

Staff Mechanical Engineer, R&D role at Johnson & Johnson supporting the development of electrophysiology catheters and systems. Responsibilities include design, requirement development, design for manufacturing, design transfer, test method development, and product verification/validation testing. Requires a Bachelor's degree in Mechanical or Biomedical Engineering with significant experience and leadership in medical device development.

What you'd actually do

  1. Lead design transfer of next-generation EP catheter platforms while strictly ensuring compliance with FDA and ISO medical device standards.
  2. Lead the design of new or existing components and/or devices while ensuring that all design requirements are met.
  3. Develop customer requirements and product specifications with validated test methods
  4. Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  5. Study specifications, engineering blueprints, tool orders, and shop data and confer with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.

Skills

Required

  • Bachelor’s Degree in Mechanical or Biomedical Engineering
  • minimum of 8 years of experience (or Master’s degree with minimum of 6 years, or PhD and 4 years)
  • Experience with CAD software such as SolidWorks
  • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
  • Strong communication skills, written and verbal
  • Ability to travel up to 25% domestic and international

Nice to have

  • early-stage (pre-design freeze) catheter and/or cardiovascular device development
  • team or project technical lead
  • product development processes
  • data analysis and statistics including design of experiments, Gage R&R, capability, etc.
  • Ability to speak Spanish

What the JD emphasized

  • strictly ensuring compliance with FDA and ISO medical device standards
  • customer requirements
  • product specifications
  • validated test methods
  • design requirements
  • health, safety and environmental standards
  • Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance