Engineer (Electrical/Mechanical/Software/Chemical) III - 7256

Conduct Manual and Automated Design V&V activities as an active member of scrum project teams designing and developing medical device software, intended for use by patients with sleep and respiratory disorders.
Software applications are developed for the Web, Client Server, Android and IOS platforms.
The successful candidate will be responsible for analyzing and verifying product requirements and designs and writing automated and manual tests at various levels to ensure that the products meet the requirements and intended use.
Tasks include:
Analyzing product and sub-system requirements.
Analyzing and verifying medical device designs.
Writing detailed automated and manual test procedures that evaluate medical device software and systems against documented requirements.
Writing the C# and/or Java code of automated tests.
Executing test procedures on a Web, Client Server, and/or Mobile phone platform.
Maintaining and controlling test execution records using good lab practices.
Technical writing, including development of test reports.
The successful candidate will demonstrate the ability to work as a member of a scrum team, solve problems, meet commitments, and ensure quality.
o Works with system level, multi-disciplined engineering projects.
o Requires limited direction.
o Makes risk-based decisions, balancing business and compliance issues.
o Plans and manages assignments of significant scope; directs other engineers.
o Communicates at all levels of the organization.
o Writes C# and/or Java code.
The successful candidate may develop relationships with teams and take on leadership roles to plan, guide, and track project efforts.
BS in Engineering, Computer, or other Science discipline, or equivalent.
2+ years with BS or MS.
o C# or Java experience oTest automation and management tools MS/VS Test, nUnit, JUnit, IntelliJ, Spring Framework, Cucumber-JVM and/or SpecFlow.
o Disciplined, regulated industries, medical device experience preferred, including FDA's 21 CFR 820/ISO 13485 experience.
o Software development using ISO 62304 or equivalent.
o Risk Management using IEC 14971 and IEC 60601 or equivalent.
o Experience testing on IOS and Android operating systems.
o Experience working with Agile methodologies.
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.
9AM-5PM M-F Required Skills:
Desired Skills:

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