R&d Engineer 2

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

R&D Engineer 2 role focused on the development of electrophysiology products, specifically ultrasound catheter technology, within the medical device industry. Responsibilities include design, test method development, product verification and validation, requirements management, and quality improvement initiatives. Requires familiarity with medical device quality and regulatory systems.

What you'd actually do

  1. Works to achieve day-to-day objectives with moderate impact on area of responsibility within the R&D Systems Engineering team. Participates in the development, testing, and deployment of ultrasound catheter technology and documents issues encountered.
  2. Develop customer requirements and product specifications with validated test methods.
  3. Works in pre-clinical lab for integration and validation of ultrasound catheter with the system.
  4. Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  5. Manage requirements, CTQ traceability, V&V planning for the new generation ultrasound device. Owning all the R&D deliverables of new product development including design and development plan, system requirements, system functional requirements, user needs etc.

Skills

Required

  • University/Bachelors Degree
  • 2 years of experience related to the position in the medical device industry
  • Familiarity with quality and regulatory systems including FDA’s Quality System Regulation, ISO13485, etc.
  • Strong verbal and written communication skills

Nice to have

  • Ability to use CAD software such as Solidworks
  • Risk Management experience
  • Bioinformatics
  • Biological Engineering
  • Biological Sciences
  • Biostatistics
  • Data Reporting
  • Data Savvy
  • Design of Experiments (DOE)
  • Detail-Oriented
  • Execution Focus
  • Feasibility Studies
  • Preclinical Research
  • Problem Solving
  • Process Oriented
  • Prototyping
  • Report Writing
  • Research and Development
  • Researching
  • SAP Product Lifecycle Management
  • Technologically Savvy

What the JD emphasized

  • Familiarity with quality and regulatory systems including FDA’s Quality System Regulation, ISO13485, etc.