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.