Medical Devices / Biomaterials We are seeking an R&D Scientist with hands-on laboratory and medical device product development experience.
Key Responsibilities:
Conduct routine/non-routine experiments and research with minimal supervision. Develop and optimize experimental methods and analyze results. Support biomaterial scale-up from laboratory to manufacturing . Ensure compliance with GMP/GxP, QSR, FDA, and safety requirements . Support method development, validation, documentation, and external testing. Collaborate with R&D, Manufacturing, Quality, and Regulatory teams.
Required/Preferred:
Bachelor's degree in a scientific discipline with 3-6 years of lab experience, or MS with 1-2 years. Medical device product development experience. Lyophilization / freeze-drying experience strongly preferred. Experience with Class
II / 510
(k) / PMA FDA-regulated medical devices preferred. Experience with biomaterials, method development/validation, and GMP/GxP environments. Strong technical writing, analytical, and problem-solving skills.