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    Principal Test Engineer - Littleton, United States - Diverse Lynx

    Diverse Lynx
    Diverse Lynx Littleton, United States

    3 weeks ago

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    Description
    Title Principal Test Engineer

    Location Littleton, MA (Onsite)

    Evaluate requirements for quality and completeness to ensure they meet the user needs

    Develop test methods to be used in evaluating X-ray image quality and consistency

    Reduce overall test burden through structured automation of existing and new testing.

    Testing of advanced image reconstruction and processing algorithms


    In conjunction with internal and external team, design custom test phantoms and fixtures to ensure functionality of new and existing features.

    Ensures compliance with standards and regulations, including ISO and FDA QSR.

    Ensures compliance with DICOM

    Participate in all phases of product development as needed such as reviewing requirements, design, usability, risk assessment and defects.

    Provide technical leadership and mentoring to other test engineers.

    Responsible for identifying and cataloging of software defects in assigned functional areas.

    Assist in triage, investigation and resolution of software defects related to x-ray image quality


    Identifies plans and executes test process improvements as a means to continually improve the performance of the Test Engineering team.

    Generates test plans and protocols based on product requirements and project needs.

    Set up and use of physical imaging phantoms

    Document and report test results

    Effectively communicate and present findings, problems, and solutions within the team including recommendations for actions and prioritization.

    Collaborate and maintain excellent working relationships with team members and stakeholders.

    Perform all activities in compliance with the Quality System.

    Performs duties in compliance with environmental, health and safety related site rules, policies or governmentalregulations.


    Solid understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971,62304, and 13485, and EU MDR.

    Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination.

    All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role.

    We promote and support a diverse workforce across all levels in the company.
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