Principal Test Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Littleton, MA 01460
Description:
Responsibilities:
- 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.
- ssist 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 governmental regulations.
- Solid understanding of federal and international medical device regulations, such as FDA QSR, ISO 14971,62304, and 13485, and EU MDR.