Senior Electro-Mechanical TMV Engineer #0568

Brief DescriptionAbout ECIECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.About The RoleECI is seeking a Senior Systems TMV (Test Method Validation) Engineer to support our client's project team, including software and systems engineers, with the full review of their existing test methods, evaluating current TMs for gaps in structure, clarity, measurement criteria, and validatability including the rewriting and restructuring of existing TMs so they are standalone, repeatable, and validation ready. The role will also support performing measurement system analysis (Gauge R&R) to demonstrate repeatability and reproducibility of each validated TM.What We Look ForHands-on experience reviewing, redeveloping, and restructuring existing electromechanical test methods. Taking current TMs and making them standalone, repeatable, and validation-readyExposure to components like compression paddle assemblies, C-arm gantry systems, detector modules, collimators, anti-scatter grids, X-ray tube/source assembliesStrong experience executing TMV protocols, physically running validation studies in a lab environment to prove TM reliabilityProficient in Gauge R&R processes; designing and executing repeatability and reproducibility studies across multiple operators and measurement setupsExperience refining TMs for measurement clarity, defining setup instructions, fixture requirements, measurement equipment, calibration needs, operator steps, and acceptance criteria so any trained operator can execute consistentlyComfortable aligning TMs to existing DV/DVal work. Familiar with precision measurement techniques (flatness, parallelism, compression force, positional accuracy) relevant to mammography device testingLab-based, hands-on execution role. Setting up fixtures, running protocols, recording data, troubleshootingUnderstanding of 21 CFR 820 / ISO 13485 and documentation rigor required in post-warning letter environmentsExperience with imaging phantoms, gel phantoms, or test consumables used in radiology/mammographyECI is an equal opportunity employer.All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.