Senior R&D Engineer, Medical Devices & Process Innovation

Katalyst CRO; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO in Tempe, AZ is seeking a senior R&D professional to lead process development for medical device projects from concept through validation. You will design and execute DOE, TMV, IQ/OQ/PQ studies and apply statistics to improve processes and products.

The role requires mentoring team members, coordinating cross-functional work, and delivering robust, compliant solutions in a regulated environment.

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

TMV

IQ/OQ/PQ

Process Validation

Statistics

Project leadership

Analytical skills

Regulated industry experience

Education

Advanced degree in Physics, Engineering, or related field

Job description

Katalyst CRO in Tempe, AZ is seeking a senior R&D professional to lead process development for medical device projects from concept through validation. You will design and execute DOE, TMV, IQ/OQ/PQ studies and apply statistics to improve processes and products.

The role requires mentoring team members, coordinating cross-functional work, and delivering robust, compliant solutions in a regulated environment.