Mechanical Test Development Engineer - Scandinavian Real Heart
Core
Develop and implement test methods and equipment for a Total Artificial Heart (TAH) to validate medical devices in R&D and production.
Role type
Mechanical Test Development Engineer
Builds
Test methods and equipment for a Total Artificial Heart
Domain
MedTech / Artificial Heart / Medical Device Testing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical engineering, test method design, test equipment development, 3D CAD (SolidWorks), technical documentation, traceability, planning and coordination
Preferred skills
Medical device industry experience, FDA regulations (21 CFR 820), ISO 13485, ISO 14971, Design of Experiments (DOE), statistical methods, quality assurance software
Technologies
SolidWorks
Responsibilities
Develop and implement test equipment and methods for medical devices, validate test methods, perform testing within R&D and production, collaborate with cross-functional teams and stakeholders to ensure testing is well planned and traceable
Seniority
Mid-Senior, hands-on IC