Principal Materials Engineer- Polymers
Basic Qualifications:
Master’s degree in Chemistry, Polymer Physics, Materials Science or Chemical Engineering and four (4) years of materials engineering experience with class II and class III medical devices. Experience must include four (4) years of experience in all the following: Identifying, developing and optimizing polymer biomaterials to include silicones and polyurethanes for implantable neurostimulators, infusion systems, and delivery tools; DOE; FTIR, GPC, MS, DSC, SEM, DMA, and tensile tests; Six-sigma and lean design; developing predictive models & transfer functions between material chemistry, properties and device performance attributes; assessing durability of materials, influences of material chemistry, manufacturing, use conditions, and biological, chemical, and pharmaceutical exposures on materials; writing technical specifications and perform failure analysis investigations; and preparing regulatory submission-ready documentation per FDA 21 CFR 820 and ISO 13485.