R&D Engineer, Medical Devices: Process Innovation Lead

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

Job summary

Katalyst CRO is seeking an experienced R&D leader to drive process development, characterization, and validation for medical devices. The role involves designing and executing DOE, TMV, IQ/OQ/PQ studies and applying statistical analysis to optimize processes and products.

You will lead complex R&D projects, mentor team members, and collaborate with cross-functional teams from research to implementation, with preference for regulated industry experience.

Qualifications

• Requires advanced degree in physics, mechanical engineering, materials science, chemistry, chemical engineering, biomedical engineering, or related field.
• 5+ years (with advanced degree) or 7+ years (with bachelor's) of R&D experience.
• Strong experience with DOE, TMV, IQ/OQ/PQ, process validation, and statistics.
• Strong analytical, troubleshooting, and project leadership skills.
• Medical device or 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 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

Statistical analysis

Problem solving

Project leadership

Mentor/team leadership

Cross-functional collaboration

Education

Advanced degree in a relevant field

Job description

Katalyst CRO is seeking an experienced R&D leader to drive process development, characterization, and validation for medical devices. The role involves designing and executing DOE, TMV, IQ/OQ/PQ studies and applying statistical analysis to optimize processes and products.

You will lead complex R&D projects, mentor team members, and collaborate with cross-functional teams from research to implementation, with preference for regulated industry experience.