Job Title: Engineer
Location: Pleasanton, CA 94588
Duration: 6 Months
Pay rate : $47 - $50/hr W2
Job Description
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 analyses 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