Principal Test Engineer - Diverse Linx

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.