Onsite: TMV Engineer (234612)

Life Sciences & Technology | Validation
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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)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
US On-Site

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