Systems Verification Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

Johnson & Johnson is seeking a Systems Verification Engineer for their Surgical Robotics system in Santa Clara, CA. The role involves designing and leading test method and equipment development, production, and qualification projects. Responsibilities include developing tests to verify safety and efficacy, executing equipment qualification, test method validation, script development, data analysis, and non-product software validation. The engineer will collaborate with cross-functional teams and ensure compliance with FDA and IEC standards. Proficiency in Python, MATLAB, or C++ is required.

What you'd actually do

  1. Design and lead test method and equipment development, production, and qualification projects for J&J Surgical Robotics system.
  2. Develop tests, tools, and processes essential to the preparation and execution of design verification.
  3. Develop tests that holistically verify the safety and efficacy of the Surgical Robotics system.
  4. Execute equipment qualification, fixture qualification (IQ/OQ), test method validation (Gage R&R), script development, analysis of data, and non-product software validation (NPSW) for design verification.
  5. Ensure produced test documentation is aligned with FDA design control processes (21 CFR820.30) and IEC 62304.
  6. Work closely with engineers from all functional teams including R&D (Mechanical, Electrical, Software, Robotics and Control), systems architecture, and quality engineering to guide requirements and product development for testability.
  7. Develop testing/analysis software scripts in Python, MATLAB, C++, or other scripting languages.

Skills

Required

  • Master's degree in Electrical, Mechanical, or Computer Systems Engineering or related field
  • 2 years of experience in Systems Verification Engineering or related occupation
  • Design verification
  • Test method and equipment development
  • Production and qualification projects
  • Safety and efficacy verification
  • Equipment qualification (IQ/OQ)
  • Test method validation (Gage R&R)
  • Script development
  • Analysis of data
  • Non-product software validation (NPSW)
  • FDA design control processes (21 CFR820.30)
  • IEC 62304
  • Collaboration with R&D, systems architecture, and quality engineering
  • Python
  • MATLAB
  • C++

What the JD emphasized

  • FDA design control processes (21 CFR820.30)
  • IEC 62304