Medical Device R&D Engineer-Process Innovation & Validation

Katalyst-Healthcares-; Cleveland (OH); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

Creative Solutions Services, LLC in Cleveland, OH, seeks an experienced R&D professional to lead medical device process development, characterization, and validation from research through implementation.

The role requires an advanced degree and 5+ years (or 7+ years with a Bachelor's) of relevant R&D experience, with expertise in DOE, TMV, IQ/OQ/PQ, and statistics to solve complex problems and guide cross-functional teams.

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.

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

Statistical analysis

Problem solving

Leadership

Mentoring

Cross-functional teamwork

DOE

TMV

IQ/OQ/PQ

Process validation

Statistics

Formation

Advanced degree in Physics or Engineering

Outils

IQ/OQ/PQ

DOE

TMV

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.