Job at a glance
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