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Medical Device Software Verification Specialist

1 month ago


Pittsburgh, Pennsylvania, United States StarsHR Inc Full time

StarsHR is seeking a skilled Medical Device Software Verification Specialist to join our team in Pittsburgh.

This long-term contract role involves verification and validation of software for complex system interactions in medical devices, including:

Application software

Embedded software

Platform software

Operating system software

The ideal candidate will have a strong background in software development lifecycle processes, including Waterfall and Agile methodologies, and excellent technical writing skills.

Responsibilities include:

Designing and developing test scenarios

Authoring and reviewing test cases and protocols

Performing execution of test cases

Verifying software platform of medical devices, including user interface and interactions, performance and reliability, safety and interoperability

Reviewing and analyzing product and software requirements

Defect characterization and reporting

Compliance with standard operating procedures for medical device development, including ISO 13485 and IEC 62304

Collaborating with cross-functional teams 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 qualifications include a Bachelor's Degree in Engineering, preferably Computer, Electronics, or Biomedical, and familiarity with tools such as Rational Quality Manager, Jenkins, TOSCA, Squish, JIRA, Git, and DOORS Next Gen.

Preferred qualifications include experience designing and developing medical device software in a regulated environment, working knowledge of OS such as Windows and Linux flavors, and demonstrated ability working in a matrix/hybrid organization structure.

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.