Principal R&d Software Engineer - Shockwave Medical

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

Principal R&D Software Engineer at Johnson & Johnson (Shockwave Medical) focused on leading technical development of innovative electronic systems for medical devices (Intravascular Lithotripsy). The role involves full lifecycle product development, including software architecture, embedded C/C++ coding (RTOS/Bare Metal), UI development, adherence to medical device standards (IEC/EN 62304), communication protocols, debugging, and regulatory compliance (FDA, ISO, MDR). Requires extensive experience with embedded processors, software development tools, and disciplined development processes within a regulated environment.

What you'd actually do

  1. Lead the software development for medical device product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements.
  2. Define architecture of software system for next generation product including the development of RTOS/Bare Metal code on embedded processor(s).
  3. Proficiency in writing code in C/C++ programming languages and understanding assembly language.
  4. Develop User Interface applications operating system.
  5. Develop code per IEC/EN 62304 medical device standard.

Skills

Required

  • Bachelor’s Degree in Software/Electrical Engineering with 10+ years’ design and development experience, or a Master’s Degree with 8+ years
  • Experience in generating technical Requirement & design specifications required for Class III medical device products
  • Extensive experience in architecting and developing Software Systems using embedded processors like Renesas, PIC32, STmicro running RTOS/Bare Metal
  • Demonstrated proficiency in C language programming for embedded ARM processors
  • Experience developing application code in C# language for Windows 10
  • Experience with setting up of communications buses between microprocessor subsystems
  • Experience in writing firmware unit test and generating test reports
  • Development of software in disciplined approach using tools for Requirement Management, Version Control and Issue tracking e.g GIT, JIRA and JAMA
  • Proficient in the use of development and debugging tools like compilers, assemblers, In-Circuit-Emulators, Oscilloscope and Logic Analyzers
  • Experience with Cross Compiler toolchains, Linkers and with build configuration files
  • Experience with designing system Architecture based on design patterns
  • Experience with automating software development processes

Nice to have

  • C++ is a plus/desirable

What the JD emphasized

  • full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements
  • IEC/EN 62304 medical device standard
  • Class III medical device products