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.