Description:Our client, as an organization, prides itself on it's award winning portfolio of injectables, devices, and skin care products to help health care professionals fuel confidence in others through aesthetic medicine. The work being done by this team provides the technology used in their devices. Our client is currently in the process of constructing a state of the art lab where the software engineers and device engineers can collaborate together towards creating new products and enhancing legacy products.This position will be responsible for developing both manual and automated testing and implementing them in industry standard testing frameworks for medical device industry. The position will be responsible to create test plan/protocol documents (both manual and automated testing) for both full verification and regression testing, execute the test plans, obtain and document the test results including test objective evidence datasheets, perform complete requirements tracing, according to department standards and SOPs. Responsible for evaluating software using automated or manual testing methods and analyzing the results. Creating testing procedures to evaluate the performance of the software. Building software testing programs that automate testing processes. Running the software testing procedures to evaluate the software. Documenting all testing procedures according to department standards and SOPs. Reporting bugs and making recommendations to improve the software product. Retesting software after bugs are fixed to ensure the program works properly. Attending meetings with the development team, stakeholders, and other groups. Perform software testing against the requirements on the medical device and emulator. Perform software unit testing for software test tools. Perform code Analysis, Profiling, and Debugging on software tools used for testing of the host application. Provide input to the software requirements for the host application and software tools. Architecting software test automation tools (C, C#, QT, Selenium or Appium). Implement the software test automation tools for the medical device host application and engineering tools (C, C#, Selenium or Appium). Responsible for documenting the test protocols, test results, and performing full requirements traceability, according to FDA 510K documentation requirements. Responsible for writing software requirements and specification documents for the test tools developed in-house Responsible for making observations, taking measurement using laboratory equipment and tools, data processing, statistical analysis and carrying out test protocols. Responsible for testing, system software debugging and troubleshooting the software (Visual Studio, QT, Selenium IDE). Work with software development in identifying the root cause to the software issues, preparing test cases, plans and procedures Approach to working technical issues that supports a schedule-oriented mindset and work ethic. Design reviews of the test tools, forms processing for software releases, documentation, other as assigned. This position requires the individual to be on-site. Perform other duties as assigned based on business needs.Skills:C, visual studio, QT, SQL, C#, Selenium, Appium, fda compliance, Python, 62304, 510k, Medical DeviceAdditional Skills & Qualifications: Master’s degree in related technical field Experience with medical device. Medical devices standards like IEC62304, ISO14971, IEC60601About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
