Medical Device Software Test Engineer

3 weeks ago

Pleasanton, United States Rangam Full time

90% Onsite

  • Must have 5+ years of current embedded Medical Device firmware/software experience.
  • The qualified candidate will work on testing medical device software against test plans, requirements and specifications.
  • The software test engineer will work closely with members of the test engineering team to identify software deviations and issues with the system.

Responsibilities:

  • Develop test cases and test scripts for Embedded Software for Medical Devices
  • Write regression and user-interface test cases for Medical Device Software
  • Perform functional testing, execute tests, record test results and create deviations
  • Analyze test results to ensure software meets the design specifications
  • Debug and troubleshoot embedded software issues
  • Monitor and report software quality metrics
  • Troubleshoot software deviations
  • Work with team of test engineers on medical devices and equipment
  • Coordinate between various groups to ensure software testing meets all requirements
  • Identify and evaluate software risks and risk mitigations
  • Develop understanding of user workflow to create, document, and execute test plans
  • Quickly become expert on system functionality, various peripheral devices as well as the requirements that drive system design
  • Create tests for ad hoc situations such as replicating field-reported problems or load testing under specific conditions
  • With minimal guidance, create test environments that mirror a multitude of installed baselines
  • Implement test processes on projects, write test plans/cases, procedures and scripts, and analyzes test results
  • Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
  • Prepare validation and performance qualification protocols for new and/or modified processes, systems, tools or equipment
  • Develop validation testing protocols
  • Author technical documents (protocols, reports, standard operating procedures) to comply with established process and regulatory requirements

Qualifications:

  • BS/BA degree in any of the following computer science, software engineering, electrical engineering, biomedical engineering, or mathematics required
  • Minimum 5 years’ experience in software development and/or testing of embedded medical devices
  • 5+ years as a software and hardware system tester, integrator, or developer.
  • Must have sufficient software/ hardware experience to build and configure workstations, understand the subsystems and their interactions in an overall system.
  • Proficient with identifying and writing up software defects for software developers
  • Programming experience with scripting languages (Perl, batch, PowerShell)
  • Experience with Windows and exposure to WinCE based devices.
  • Proficient with the characterization of software deviations
  • Experienced in software verification and validation strategies.
  • Experienced in Implementing test processes on projects, write test plans/cases, procedures and scripts, and analyzes test results.
  • Strong analytical and problem-solving skills is a must
  • Strong oral and written communication skills
  • Must work well in a team environment, be highly motivated, and willing to learn new skills.
  • Good communications and documentation skills, including experience in writing SOPs, work instructions, training and other relevant documentation.
  • Experience working with manufacturing, development and production teams or groups.
  • Previous experience with testing in a medical device manufacturing environment subject to FDA compliance is a plus.

What are the top 3-5 skills requirements should this person have

  • Experience testing class II/III medical device software.
  • Experience with Windows applications and embedded firmware.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification

  • Experience writing software requirements. Experience building and releasing software/firmware.
  • Experience with Arena, Axosoft and Helix ALM (former TestTrack) tools

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