Posting ID: 7342595
* Conduct biocompatibility studies for new and in-process products.
* Serve as study director (Interpret data and define qualification strategies for new or modified devices or processes)
* Lead biocompatibility studies for new and in-process products including testing (e.g., cytotoxicity, hemolysis, systemic toxicity, intracutaneous reactivity, implantation testing, sensitization testing, VOC testing).
* Collaborate with project teams to establish test recommendations and testing in compliance with biocompatibility guidelines by ISO10993.
* Review and interpret test results for biocompatibility studies.
* Develop non-routine protocols, reports, and methods
* Make appropriate recommendations to improve the quality testing activities including product and safety related issues.
* Write, review, and approve protocols and reports pertaining to biocompatibility.
* Application of GLP regulations and ISO 10993 Biological Evaluation of Medical Devices.
* Analyzes chemical, biological or microbiological products, raw materials, in-process materials, release test samples or stability samples in support of the company's quality program.
* Work with design teams, to create up front initial design requirements to comply with biocompatibility requirements from US and OUS agencies
Experience with analytical chemistry, chemistry analysis quantifying in experiments background will be helpful
-Minimum of Master's +3 years relevant experience or PHD with 2 years of experience
-Medical Device experience.
-Worked in an FDA environment
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing® winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.
Recruiter: Natalie Kennemore
Phone: (714) 347-1238