Roles & Responsibilities:
- Candidate must possess a bachelor's degree in engineering, or a scientific or quality assurance discipline.
- wareness of Design controls and change controls for FDA regulated medical devices (21 CFR 820.20 and ISO13285 standards)
- wareness of Test Method Validation, Installation Qualification, and related Statistics: Study design, DOE, TM Characterization, Data Analysis (Gage R&R, Correlation, etc.), Test method validation study.
- bility to create technical documentation including TMC, IQ, TMV, and Generic Verification protocols and reports.
- Understanding of test fixtures and test equipment such as tensile frames.
- Excellent written and oral communications. Ability to summarize and consolidate data and information in presentation form for cross-functional discussion.
- bility to work remotely with advance proficiency in software applications: MS Office (Outlook, Word, Excel, PowerPoint, and MS Teams).
- bility to work autonomously across functional boundaries to complete projects within required timeframes while being part of a team.