Software Engineer IV


Associate Staffing


Posted Under: Indianapolis, Indiana jobs in IT / Software / Systems; IT / Software / Systems jobs in zipcode 46296
Posted On: 2021-02-23

The Software Engineer IV is responsible for managing the software development roadmap, including assigning tasks to other software engineers, developing projects, and implementing effective and high-quality software solutions. Duties and Responsibilities
  • Manage software engineers and software development projects to implement effective and high-quality software solutions;
  • Collect, analyze, and document user requirements;
  • Perform project management, ensure system quality and oversee content management;
  • Coordinate with CTO and company-wide leadership regarding software development projects;
  • Design, modify, develop, support, install, and document HIPAA compliance software applications, including HIFU Treatment software, graphical user interface software, and probe motion control software;
  • Participate in software quality control and validation processes through development, code review, and/or execution of test plan/cases/scripts;
  • Train software engineers and applicable employees throughout company;
  • Identify process deficiencies and propose improvements;
  • Assist Hardware Development teams with design and testing of custom electronics, to the extent they require software;
  • All other duties as assigned Qualifications/Specifications
    • Six years of software development experience, required;
    • Three years of project lead experience, preferred;
    • Development Experience with Java, JNI, C++, and Windows Environments, required;
    • Experience with international standards for quality systems, required;
    • Knowledge of SharePoint technologies preferred;
    • Understanding of software development processes within a medical device manufacturing environment, including general knowledge of Good Manufacturing Practices, Good Engineering Practices, FDA Quality System Regulation, ISO 13485, Healthcare compliance, and applicable regulations and industry standards regarding clinical research and regulation of medical devices;
    • General knowledge of IEC 62304 Medical Device Software - Software Life Cycle Processes, FDA General Principles of Software Validation Final Guidance for Industry and Staff, FDA Guidance for the Content of Premarket submissions for Software Contained in Medical Devices;
    • Experience in clinical environments a plus!

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