Medical Device V&V Engineer

1 month ago

Pittsburgh, United States StarsHR Inc Full time

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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