Duration
6-9 months
Job Description
Our medical device client is currently seeking a Test Method Validation (TMV) Engineer to assist with TMV efforts, equipment validation, facilitate database testing, report writing and documentation activities. The client about 20+ test methods they have developed during the R&D process. The first couple of weeks will consist of onboarding and reading documentation, obtaining familiarity with the product (catheter) and review of: design requirements, matrices, verification plans, SOP’s. Following onboarding, the next objective will be understanding testing requirements that are needed in order to submit a 510k. Familiarity with applicable ISO standards such as ISO 10555, GMP and good documentation practices. MUST HAVE at least 2 recent years of hands-on TMV experience for medical device companies related to vascular access products (stints, catheters, cardiovascular or blood devices, etc). Working knowledge with Minitab will be helpful.
Onsite: TMV Engineer (234612)
