Description
Tasks include:
- Analyzing product and sub-system requirements.
- Analyzing and verifying medical device designs.
- Writing detailed test procedures that evaluate medical devices and systems against documented software requirements.
- Executing test procedures on a Web, Client Server or Mobile phone platform.
- Maintaining and controlling test execution records using good lab practices.
- Technical writing, including development of test reports.
BEHAVIORS:
- The successful candidate will demonstrate the ability to work as a member of a team, solve problems, meet commitments, and ensure quality.
- Works with system level, multi-disciplined engineering projects.
- Requires limited direction
- Makes risk-based decisions, balancing business and compliance issues.
- Plans and manages assignments of significant scope; may direct other engineers.
- Communicates at all levels of the organziation.
PREFERRED EXPERIENCE:
- Disciplined, regulated industries, medical device experience preferred, including FDA's 21 CFR 820/ISO 13485 experience.
- Software development using ISO 62304 or equivalent.
- Risk Management using IEC 14971 and IEC 60601 or equivalent.
ADDITIONAL EXPERIENCE DESIRED:
- Test automation and management tools, such as CodedUI, Selenium, JUnit, NUnit, Cucumber, SpecFlow.
- C# or Java experience