Senior Test Method Validation (TMV) Subject Matter Expert (SME) / Lead

Less of a LEAD and MORE of an SME Hands On Senior Level Subject Matter Expert

ONSITE

Title: TMV Engineer SME
Daily duties of the contractor:

TMV Engineer/specialist Key Requirement and experience:

Develop and validate test methods for complex electromechanical medical device systems to verify essential clinical and system performance requirements.
Demonstrate expertise in converting design and clinical requirements into repeatable, reproducible, and validation-ready test methods, including development of protocols, fixtures, measurement techniques, acceptance criteria, and Test Method Validation (TMV) studies.
Lead test method development and execution of Gauge R&R, repeatability and reproducibility assessments, measurement system analysis, and documentation compliant with FDA 21 CFR Part 820 and ISO 13485 requirements.
Performed hands-on laboratory testing, data collection, troubleshooting, and statistical analysis to support design verification and validation activities.
Create TMV protocols and reports demonstrating accuracy, precision, repeatability, reproducibility, and robustness of measurement methods.
TMV analysis - Identifying measurement and control requirements for the method, Identifying equipment and assessing its suitability to the test method, Identifying sources of variability for the method and assessing if MSA is required.
Act as SME/Mentor for junior engineers

Desired Experience
Develop test methods for complex electromechanical subsystems such as motion systems, detectors, gantries, compression mechanisms, sensors, and imaging components.
Experience in design verification software tool validation.
Worked within Design Verification (DV) and Design Validation (DVal) frameworks, ensuring traceability between requirements, test methods, and objective evidence
Experience supporting products with clinical performance requirements and regulated medical-device development environments.

Skills:
Must Skills: Engineering Degree, TMV expertise, Statistics
Plus Skills: Experience with complex imaging products