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StarsHR has the following long-term contract opportunity available with our client in Greater Pittsburgh.
Embedded Software V&V Engineer
SUMMARY
This position will be responsible to perform software verification and validation of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.
DUTIES & RESPONSIBILITIES
· Verification and Validation of software for complex system interactions in medical devices, including
· 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
· Writing reports
· Responsible for verification of the software platform of the medical device, including:
· Sub-system testing
· 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.
REQUIREMENTS
· Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical
· Minimum of 2 years of relevant work experience in software testing in medical device or in a regulated industry
· Minimum of 1 years of relevant work experience in software test automation
· Familiarity with Software Development Lifecycle processes, including Waterfall and Agile methodologies
– Familiarity with C/C++, Python languages and test frameworks.
– Understands impacts of hardware constraints on software environment.
– Familiarity with ST microprocessor, FPGA, BLDC, peripheral device communication and embedded RTOS
– 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.
This position is a long-term contract, potentially leading to perm. StarsHR can provide benefits while contracting through our company.
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