Senior R&D Engineer - Medical Device Process Innovator

Katalyst CRO; Sacramento (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Sacramento seeks a senior R&D leader to drive process development, characterization, and validation for medical device programs. You will design and execute DOE, TMV, IQ/OQ/PQ studies and apply statistical analysis to improve processes and products.

The role requires a strong background in process development, statistics, and project leadership, with preference for regulated medical device experience. On-site position in California with cross-functional collaboration.

Qualifications

• 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.

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

Process Characterization

TMV

IQ/OQ/PQ

Process Validation

Statistics

Leadership

Analytical Thinking

Education

Advanced degree in relevant field

Job description

Katalyst CRO in Sacramento seeks a senior R&D leader to drive process development, characterization, and validation for medical device programs. You will design and execute DOE, TMV, IQ/OQ/PQ studies and apply statistical analysis to improve processes and products.

The role requires a strong background in process development, statistics, and project leadership, with preference for regulated medical device experience. On-site position in California with cross-functional collaboration.