Medical Device R&D Scientist – Product Development

Medical Device R&D Scientist – Product Development

Experience: 3–6 years (BS) / 1–2 years (MS)

Industry: 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.