R-D Engineer

The R&D Engineer is responsible for leading process development, characterization, and validation activities for medical device products. This role designs and executes DOE, TMV, PCR, and IQ/OQ/PQ studies, applies statistical analysis to optimize manufacturing processes, and supports product development from research through commercialization. The engineer collaborates with cross-functional teams, drives process improvements, provides technical leadership, and ensures compliance with quality and regulatory requirements within a regulated medical device environment.

• 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.
• 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.