The Software Test Engineer validates software products using systematic tests to develop, apply, and maintain quality standards for company products. Develops, modifies, and executes software test plans and test protocols and automated software. Analyzes test results to ensure existing functionality and recommends corrective action. Consults with software development engineers in resolution of problems.
This role is onsite in Germantown, MD.
Duties and Responsibilities include, but are not limited to:
- Review of the software development and testing activities per IEC 62304
- Apply Software Quality Engineering principles throughout the agile product life cycle to identify defects and design flaws
- Review the software requirements to ensure that requirements stated are correct, unambiguous and verifiable
- Develop Test Plans against Use Cases, Requirements and assist in updating and adding new test cases to existing test Protocol.
- Manage Testing tasks for Embedded Software.
- Review test methods and test plans for software projects to determine the software design accuracy according to documented requirements as well as established standards
- Collaborate with the development team to improve the quality of the deliverables and to introduce other quality related improvements in software process
- Prepare & Review test plans & test data and conduct system and integration testing.
- Integrate automated tests into Continuous Integration and Continuous Deployment pipelines for real-time quality monitoring.
Knowledge, Skills, Abilities and Requirements:
- BS degree in Engineering (Electrical, Mechanical, Software or Biomedical), Computer Science, Physics or other relevant technical discipline or equivalent, advanced degree (Masters) preferred
- Minimum of 5 years of experience in medical device software, preferably in embedded, mobile and cloud server applications
- Experienced in Good Documentation Practices
- Experience working in a regulated environment.
- Experience in IEC 62304, ISO 13485, and FDA 21 CFR Part 820 standards within a medical product development environment.
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