Medical Device V&V Engineer
1 day ago
StarsHR has the following long-term contract role available with our client in Pittsburgh.
Medical Device V&V Engineer
Duties:
Verification and Validation of software for complex system interactions in medical devices, including
Application software
Embedded software
Platform software
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
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
Review and analysis of product and software requirements
Defect characterization and reporting. Assist in triaging of the defects.
Compliance with standard operating procedures for medical device development, including compliance with ISO 13485 and IEC 62304
Critical analysis of technical situations; identifies problems, and work with the cross-functional team in resolving the problems.
Collaborating within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in medical device R&D activities
Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function.
Required:
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 (testers, auditors, peers, etc.)
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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