Senior Test Method Validation Engineer
Listed on 2026-09-02
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Engineering
Quality Engineering, Biomedical Engineer, Test Engineer, Medical Device Industry
Senior TMV Engineer
Required Skills & Experience- BS in Mechanical, Biomedical, Plastics Engineering, or related field
- 7+ years of medical device engineering experience
- Experience with Class II medical devices
- Strong TMV, Design Verification, and V&V experience
- Experience authoring protocols, test methods, reports, and verification documents
- Knowledge of Design Controls and DHF requirements
- Experience in a regulated product development environment
- Strong technical writing skills
- Ability to independently execute testing and analyze results
- Experience troubleshooting test failures and technical issues
- Nice to Have Skills & Experience
- Endoscopy, catheter, or minimally invasive device experience - New Product Development (NPD) experience
- Experience with airflow, force, and performance testing
- Minitab or statistical analysis tool experience
- Solid Works proficiency
- Test fixture design/development experience
- Experience with Instron machines, flow meters, pressure gauges, and validation equipment
- Knowledge of Gauge R&R and measurement system analysis
- Experience developing or validating complex medical device test methods
Job Description
We are seeking a Senior TMV Engineer to support new product development efforts within a regulated medical device environment. This individual will play a key role in test method validation (TMV), design verification activities, technical documentation, and test execution for next-generation endoscopy products. The ideal candidate will have experience working within a Design Control environment and be comfortable balancing hands-on laboratory testing with technical report writing and documentation.
This position will partner closely with R&D and Design Quality teams throughout the product development lifecycle. Responsibilities
- Execute test method validation (TMV) and design verification (TDV) activities
- Author and maintain TMV protocols, reports, test methods, and technical documentation
- Perform testing and analysis for medical device product development projects
- Collect, analyze, and document test data and results
- Troubleshoot test failures and support root cause investigations
- Support development and improvement of test fixtures and setups
- Operate laboratory equipment including Instron testing systems, flow meters, pressure gauges, and related measurement tools
- Collaborate with cross-functional teams including R&D and Design Quality Assurance (DQA)
- Support Design History File (DHF) documentation and Design Control requirements
Compensation: $80/hr to $84/hr exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.
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