Job Description
Job Description
Job Description:
Must Have:
- Bachelor's Degree in Engineering, Science or technical field with 1+ years of work experience in Engineering and/or Quality
- Experience in Reliability Testing, Design Verification, Test Method Validation and strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team
Nice To Have:
- 1+ 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, Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
Top 3 skills:
- Reliability Engineering,
- Test Method Development,
- Test Method Validation
Can you please confirm the 3 main responsibilities/day to day activities required for this role:
- Setup and execution of test methods for Test Method Validation or Design Verification,
- Report writing and approval,
- Review of design, manufacturing and supplier change orders.
Products (if any) will this role support: Affera Disposable products: Sphere-9, Tubing Set, and Extension Cable
Years of experience: 2-4 years