Senior Clinical Research Engineer
Core
Lead and execute clinical research activities, translating clinical needs into technical requirements for innovative medical devices.
Role type
Senior Clinical Research Engineer
Builds
Medical devices and technologies
Domain
Medical Technology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design and execution, Regulatory compliance (FDA, EU MDR, GCP), Data analysis and reporting, Protocol development, Cross-functional collaboration, Risk assessment, Usability testing, Mentorship
Preferred skills
New product development (NPD) experience, Master's Degree
Technologies
GCP, ISO 14155, FDA, EU MDR
Responsibilities
Design and execute clinical studies from concept to post-market surveillance, Translate clinical needs into technical requirements, Develop and validate study protocols and documentation, Analyze and report clinical study results, Collaborate with external investigators and clinicians, Provide technical expertise during product development lifecycle, Mentor junior associates
Seniority
Senior, hands-on IC