Description: Sr. Test Engineer
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 anomalies and issues with the system.
- Troubleshoot software anomalies
- Work with a 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.
- Write regression and user-interface test cases.
- Develop understanding of user workflow to create, document, and execute test plans.
- The tester must quickly become expert on system functionality and that of various peripheral devices as well as the requirements that drove system design.
- May be asked to create tests for ad hoc situations such as replicating field-reported problems or load testing under specific conditions.
- independently or with minimal guidance to 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.
- Perform functional testing Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products
- Establish validation standards and develop testing protocols
- Prepare validation and performance qualification protocols for new and/or modified processes, systems or equipment for medical devices.
- Author technical documents (protocols, reports, standard operating procedures) to comply with regulatory requirements
- BS in any of the following computer science, software engineering, electrical engineering, or mathematics degree required
- Minimum 6 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 anomalies
- 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.