Principal Test Engineer

Title Principal Test Engineer

Location Littleton, MA (Onsite)

Client Medtronic

Visa Any valid visa except OPT/CPT/J1

Salary $80,000-85,000/annum

This position is for a novel or a new imaging modality / function / technology that MDT has developed in their OARM product. Currently this is in the early product development stage (innovation stage). Since this functionality is new to the industry there is no pre-defined process / industry standard to test.

So, the expectation from the new engr is to design test tool/fixture and define the test methodology, establish the method and streamline it. It has to be inline with the current test practices so that it is effective with the hospital radiologist / service technicians. (currently what they have is a very rudimentary way of testing to validate as part of R&D work). It will be mostly manual, though there is a plan to automate at a later date, when test processes are finalized. (so test automation skills are more of nice to have at the moment)

Following skills/exp would be of prime importance:

1. Very good experience in image quality evaluation, testing various image modalities etc..,

2. Know-how on how periodic test / calibrations are done on imaging equipment like O-arm, C-arm or any other Xray machine

3. Experience in developing test methods and processes

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.