Description:
Responsibilities:
- Perform design verification activities including test method development, sample size rationale, and product acquisitions to support all products (as needed).
- Perform test method validation activities using appropriate statistical methodologies.
- Perform reliability activities to resolve product related issues (manufacturing, field complaints, etc.)
- Apply critical thinking to determine the need for further actions or to document audit defendable rationales when no further actions are required.
- Update Risk Management files (Risk Management Report, Product Hazard Analysis, DFMEA, etc.) including risk assessments for projects and issue understanding as needed.
Required Qualifications:
- Bachelor's degree in Engineering, Science, or related technical discipline.
- 2-4 years of experience is required.
- Reliability Engineering
- Test Method Development
- Test Method Validation
Preferred Qualifications:
- 1-3 years of Medical Device industry experience.
- Familiar with FDA 21 CFR Part 820, EU 217/745 (EU MDR),
- Familiar with these standards: ISO 13485, ISO 14971, IEC 60601