R&D Engineer, Medical Devices & Process Validation

Katalyst-Healthcares-; Albuquerque (NM); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC is seeking a senior R&D professional to lead process development and validation for medical device projects in the United States. You will design and run DOE, TMV, PCR, IQ/OQ/PQ studies, and apply statistics to optimize processes and products.

The role requires mentoring, cross-functional collaboration, and strong leadership to drive complex R&D initiatives from research through implementation while leveraging experience in regulated medical device environments.

Qualifications

• Advanced degree requirement in a relevant science/engineering field.
• 5+ years (advanced degree) or 7+ years (Bachelor's) of 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.

Responsabilités

• 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.

Connaissances

Process development

DOE

Statistics

Project leadership

Troubleshooting

Mentoring

Cross-functional collaboration

Formation

Advanced degree in Physics/Mechanical Eng./Materials Sci./Chemistry/Chemical Eng./Biomedical Eng. or related field

Bachelor's degree in a related field

Description du poste

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.