R&D Engineer

Katalyst CRO; Cleveland (OH); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO is seeking an experienced R&D leader to drive development, characterization, and validation of medical device processes in a fast-paced environment. You'll design and execute DOE, TMV, IQ/OQ/PQ studies, applying rigorous statistics to solve complex problems and improve products.

You will mentor senior and junior engineers and collaborate across cross-functional teams to move projects from research to implementation.

Qualifications

• Advanced degree or equivalent experience in a relevant scientific/engineering field.
• Experience with process development and validation in medical device R&D.
• Strong statistical and problem-solving skills; leadership experience.

Responsibilities

• Lead development, characterization, and validation of medical device processes.
• Design/execute DOE, TMV, IQ/OQ/PQ studies.
• Apply statistical analysis to drive process improvements.
• Mentor team members and coordinate cross-functional projects.
• Support product development from research to implementation.

Skills

Process Development

DOE

Process Characterization

TMV

IQ/OQ/PQ

Statistics

Project Leadership

Education

Advanced degree in Physics/Engineering or related field

Bachelor's degree in a relevant field

Job description

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.