The company is looking to solve the problem of ensuring the quality and reliability of medical device software for patients with sleep and respiratory disorders by conducting Manual and Automated Design V&V activities.
Requirements
- C or Java experience
- Test automation and management tools MS/VS Test, nUnit, JUnit, IntelliJ, Spring Framework, Cucumber-JVM and/or SpecFlow
- 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
- Experience testing on IOS and Android operating systems
- Experience working with Agile methodologies
Responsibilities
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- Analyzing product and sub-system requirements.
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- Analyzing and verifying medical device designs.
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- Writing detailed automated and manual test procedures that evaluate medical device software and systems against documented requirements.
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- Writing the C and/or Java code of automated tests.
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- Executing test procedures on a Web, Client Server, and/or Mobile phone platform.
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- Maintaining and controlling test execution records using good lab practices.
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- Technical writing, including development of test reports.
Other
- BS in Engineering, Computer, or other Science discipline, or equivalent
- 2+ years with BS or MS
- Physical Requirements: Sedentary desk/office job with frequent lifting of up to 10 pounds; requires physical skills to operate computer and other mechanical/electrical equipment
- Ability to work as a member of a scrum team, solve problems, meet commitments, and ensure quality
- Communicates at all levels of the organization
