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Duration: 6 months Contract

Job Description:

+ System software verification and validation of radiology device products to meet FDA design controls

+ 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.

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.

Experience:

+ 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 RTOSTechnical writing ability – clear and concise writing easily understood by multiple audiences (testers, auditors, peers, etc.)

+ Have a strong sense of ownership and project outcome.

Skills:

+ 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, GoogleTest, JIRA, Artifactory, 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

Education:

+ Bachelor’s degree in engineering, preferably Computer, Electronics, or Biomedical

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.