About the role
Job Title: Test Method Validation (TMV) Engineer
Location: United states
Duration: 12 Months Contract
Job Summary
We are seeking an experienced Test Method Validation (TMV) Engineer to support the development, validation, and verification of complex electromechanical medical devices. The ideal candidate will have hands-on experience developing test methods, performing statistical analysis, executing Design Verification (DV) and Design Validation (DVal) activities, and ensuring compliance with FDA and ISO 13485 regulations.
Key Responsibilities
- Develop, qualify, and validate test methods for complex electromechanical medical devices.
- Create and execute Test Method Validation (TMV) protocols and reports.
- Perform repeatability, reproducibility, accuracy, precision, linearity, and robustness studies.
- Conduct Gauge R&R, Measurement System Analysis (MSA), and statistical analysis to support verification activities.
- Translate design inputs and clinical requirements into validated test methods, fixtures, acceptance criteria, and measurement techniques.
- Perform hands-on testing, troubleshooting, data collection, and analysis.
- Support Design Verification (DV) and Design Validation (DVal) activities while maintaining full requirements traceability.
- Develop and maintain validation documentation in compliance with FDA, ISO 13485, and Design Control requirements.
- Collaborate with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to support product development and validation activities.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related engineering discipline.
- Experience developing and validating test methods for medical devices.
- Strong knowledge of Test Method Validation (TMV), Measurement System Analysis (MSA), and Gauge R&R.
- Experience supporting Design Verification (DV) and Design Validation (DVal).
- Experience with statistical analysis and validation documentation.
- Knowledge of FDA regulations, ISO 13485, and medical device Design Controls.
- Strong analytical, troubleshooting, and documentation skills.
Preferred Qualifications
- Experience working with electromechanical medical devices.
- Experience with motion systems, sensors, imaging systems, detectors, gantries, or similar electromechanical subsystems.
- Experience with Design Verification software tool validation.
- Experience in medical device product development within a regulated environment.
- Experience supporting clinical performance testing and requirements verification.
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at Intellectt Inc was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.