R&D Engineer

Katalyst-Healthcares-; Sacramento (CA); Presencial; USD 100.000 - 160.000; Jornada completa

Descripción de la vacante

Creative Solutions Services, LLC is seeking a senior R&D professional to lead process development, characterization, and validation for medical device projects.

You will design and execute DOE, TMV, PCR, IQ/OQ/PQ studies, applying statistics to improve processes. You’ll mentor engineers and drive cross-functional collaboration from research through implementation.

Formación

• Advanced degree in a relevant scientific or engineering field.
• 5+ years with an advanced degree or 7+ years with a bachelor’s in R&D.
• Experience with regulated medical device development preferred.

Responsabilidades

• 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.

Conocimientos

Process Development

DOE

Process Characterization

TMV

IQ/OQ/PQ

Process Validation

Statistics

Project Leadership

Analytical Troubleshooting

Educación

Advanced degree in Physics/Engineering/Materials/Chemistry/Biomedical Eng

Bachelor’s degree in related field

Descripción del empleo

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.