Medical Device Software Verification and Validation Engineer

4 weeks ago


Pittsburgh, Pennsylvania, United States StarsHR, Inc. Full time

StarsHR is seeking a highly skilled Medical Device Software Verification and Validation Engineer to join our client in Pittsburgh.

Job Summary:

The successful candidate will be responsible for the verification and validation of software for complex system interactions in medical devices.

Key Responsibilities:

Verification and validation of software for complex system interactions in medical devices, including application software, embedded software, platform software, and operating system software.

Development and execution of manual and/or automated software verification protocols, including design and development of test scenarios, authoring and review of test cases and protocols, and performing execution of test cases.

Responsible for verification of the software platform of the medical device, including user interface and interactions, performance and reliability, safety and interoperability, and review and analysis of product and software requirements.

Defect characterization and reporting, and assist in triaging of defects.

Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304.

Requirements:

Bachelor's Degree in Engineering, preferably Computer, Electronics, or Biomedical.

Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies.

Technical writing ability, clear and concise writing easily understood by multiple audiences.

Preferences:

Experience designing and developing medical device software in a regulated environment while adhering to FDA Design Controls and software process guidelines for medical devices including ISO 13485 and IEC 62304.

Working knowledge of tools such as Rational Quality Manager, Jenkins, TOSCA, Squish, JIRA, Git, and DOORS Next Gen.

Working knowledge on OS such as Windows, Linux flavors.

Demonstrated ability working in a matrix/hybrid organization structure.

Ability to troubleshoot and make quick knowledge and experience-guided decisions.

Excellent written and oral communication.

Excellent people skills, ability to partner well, good team camaraderie.

Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools.

This is a long-term contract assignment which may lead to perm. StarsHR can provide benefits while contracting through our firm. Sponsorship is available for well-qualified candidates.

C2C is NOT PERMITTED by our client and ABSOLUTELY NO VENDOR INQUIRIES will be entertained.



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