.NET Developer for Azure

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.