Job Title: Engineer III (Software Test Engineer)
Duration: 6+ Months
Location: Pleasanton, CA (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 analyze 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.
- Experience
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
Interview:
1st round: 30 min video interview
2nd round: 60 min video interview
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