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Embedded Software-Medical Devices

3 months ago

Minneapolis, United States Critical Fit Recruiting Full time

RESPONSIBILITIES:

  • Design, implement, test, debug, and document integration solutions and enhance existing components to ensure that software meets the business needs, while in compliance with applicable regulations and processes.
  • Lead debugging efforts, root cause investigations, and issue resolution.
  • Responsible for functional and design specifications and design reviews.
  • Responsible for managing and overseeing the design and development of new software or extensive software revisions.
  • Select and utilize tools and methodologies to ensure that software tests identify defects and comply with quality standards.
  • Support software quality assurance methodologies, systems, and practices which meet company, customer, and regulatory requirements.
  • Support documentation efforts associated with planning, intended use, user requirements, hazard analysis, functional and design specifications, design reviews, V&V test plans/protocols/reports and traceability.
  • Support the creation of test plans, test cases, and automation for new features and enhancements to existing features.
  • Support SW/FW V&V efforts.
  • Assist in workload planning and time estimation.
BACKGROUND PROFILE:
  • Bachelor's degree in Computer Science, Engineering or related field with seven or more years of experience in software engineering OR Master's degree in Computer Science, Engineering or related field with five or more years of experience in software engineering.
  • Experience working in an Agile software development environment.
  • Familiarity with bare metal and RTOS based embedded solutions, BLE, USB, typical embedded communication interfaces such as I2C, SPI, etc.
  • Experience working (design, test, etc) within a regulated environment (FDA, MDR, etc)
  • Working knowledge of C#, Visual Studio, .net, Azure DevOps, Git, Jira, Jama and standard office software.
  • Familiar with IEC 62304, ISO 14708