Translational Research Scientist
Core
Lead translational research to understand mechanisms of action for medical interventions, translating biological and engineering insights into device design and clinical study plans for Class II and III pulmonary medical devices.
Role type
Senior Translational Research Scientist (Medical Devices)
Builds
Translational study plans, experimental models, and data packages supporting regulatory submissions and product development for next-generation pulmonary devices.
Domain
Medical Devices / Pulmonology / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Study design and execution (in vitro, ex vivo, in vivo), GLP/GCP compliance, data analysis and synthesis, external collaborator management, regulatory pathway understanding, team leadership and mentorship, cross-functional strategy alignment.
Preferred skills
Laboratory management experience, CRO partnership negotiation, FDA/EU regulatory submission design, academic collaboration establishment.
Technologies
GLP/GCP frameworks, biospecimen processing platforms, data storage and sharing systems, imaging and staining automation tools.
Responsibilities
Design and execute translational study plans to evaluate mechanism of action, performance, and safety; develop and validate experimental models and protocols; manage data integrity and documentation per GLP/GCP; build and maintain relationships with external investigators and labs; translate clinical findings into actionable inputs for product design; lead and mentor a growing team of translational scientists; coordinate cross-functionally with engineering, clinical, regulatory, and commercial teams.
Seniority
Senior, hands-on IC with team leadership responsibilities
