Medical Device R&D Engineer - Process Dev & Validation

Katalyst CRO; Albuquerque (NM); On-site; USD 95,000 - 150,000; Full time

Job summary

Katalyst CRO in Albuquerque, NM seeks an experienced R&D Scientist to lead process development, characterization, and validation for medical device programs. You will design and execute DOE, TMV, PCR, IQ/OQ/PQ studies and apply statistical analysis to improve processes and products.

This role requires an advanced degree and 5+ years (or 7+ with a Bachelor's) of relevant R&D experience, with strong leadership, cross-functional collaboration, and a track record in regulated medical device

Qualifications

• Advanced degree in a relevant STEM field is required.
• 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.

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.

Skills

Process development

DOE

TMV

IQ/OQ/PQ

Statistics

Project leadership

Education

Advanced degree in Physics, Mechanical Engineering, Materials Science, Chemistry, Chemical Engineering, Biomedical Engineering, or related field

Job description

Katalyst CRO in Albuquerque, NM seeks an experienced R&D Scientist to lead process development, characterization, and validation for medical device programs. You will design and execute DOE, TMV, PCR, IQ/OQ/PQ studies and apply statistical analysis to improve processes and products.

This role requires an advanced degree and 5+ years (or 7+ with a Bachelor's) of relevant R&D experience, with strong leadership, cross-functional collaboration, and a track record in regulated medical device