• Staff Software Engineer

    Fresenius Medical Care North AmericaLawrence, MA 01842

    Job #2692934225

  • Position Summary

    The individual in this role will support activities related to the design, development, and manufacturing of our equipment products.

    Core Responsibilities

    • Lead major projects, or phases of projects

    • Resolve advanced and complex technical challenges

    • Create software architecture (embedded, O.S., and Application layer) for complex electromechanical devices · Software/sensor algorithm development and optimization and/or Machine Learning Algorithm development.

    • Perform Risk Analyses, including Fault Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), and Cybersecurity Analysis in compliance with applicable standards

    • Lead Risk Management activities to ensure compliance with applicable design- and process-related standards

    • Lead the product development team in the adoption and use of best practice software design methodologies

    • Debug designs

    • Provide technical support for product development, as well as systems integration and testing

    • Investigate the feasibility of new projects, systems, or approaches

    • Mentor other engineers in good coding practices, debugging techniques, etc.

    • Work with Quality Assurance to maintain an approved internal Quality System that meets the requirements of GMP's, QSR, ISO 13485 , and IEC62304

    Requirements

    • BS in Software Engineering, Electrical Engineering, or equivalent

    • MS/ME in relevant disciplines is strongly Preferred

    • 10+ years of experience in software product engineering and development

    · Hands-on technical leader/mentor for a team of senior and mid-level engineers.

    · C and/or C++ Language Skills

    · Must have Medical device or other safety critical device development experience

    • Able to generate thorough and comprehensible documentation - requirements through software, as well as risk documentation.

    • Experience with embedded systems development

    • Experience with sensors, CAN, A/D, embedded operating systems, multiple processor systems

    • Proven ability to run major software development projects from concept to manufacturing

    • Proven advanced technical knowledge in software development methodologies

    • Demonstrated expert analytical and design skills

    • Proven knowledge of project lifestyles, software development environments, and source control techniques