Responsibilities:
Lead process development, characterization, and validation for medical device R&D.
Design and execute DOE, TMV, PCR, IQ/OQ/PQ studies.
Apply statistical analysis and advanced problem-solving to improve processes and products.
Lead complex R&D projects, mentor team members, and collaborate with cross-functional teams.
Support product development from research through implementation.
Requirements:
Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or related field.
5+ years (Advanced Degree) or 7+ years (Bachelor's) of relevant R&D experience.
Strong experience with Process Development, DOE, Process Characterization, TMV, IQ/OQ/PQ, Process Validation, and Statistics.
Strong analytical, troubleshooting, and project leadership skills.
Medical device/regulated industry experience preferred.
