Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or related field.
5+ years of relevant R&D experience for advanced degree holders, or 7+ years for those with a bachelor's degree.
Strong experience in Process Development, DOE, Process Characterization, TMV, IQ/OQ/PQ, and Process Validation.
Solid analytical and troubleshooting skills necessary for project leadership.
Experience in the medical device or regulated industry is preferred.
Responsibilities
Lead development, characterization, and validation of processes for medical device R&D.
Design and execute Design of Experiments (DOE), Test Method Validation (TMV), and Installation/Operational/Performance Qualification (IQ/OQ/PQ) studies.
Apply statistical analysis and advanced problem-solving methods to enhance processes and products.
Manage complex R&D projects while mentoring team members and collaborating with cross-functional groups.
Support all phases of product development from research to implementation.
Full Job Description
Responsibilities:
Lead process development, characterization, and validation for medical device R&D.
Design and execute DOE, TMV, PCR, IQ/OQ/PQ studies.
pply 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:
dvanced 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.
