Senior Mechatronics Engineer
Core
Lead on-market mechatronic devices and consumables for implantable and extracorporeal blood pump systems, managing manufacturing, regulatory, and quality aspects.
Role type
Senior Mechatronics Engineer (Medical Devices)
Builds
Implantable and extracorporeal blood pump systems (CentriMag, HeartMate 3)
Domain
MedTech / Cardiovascular / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechatronics, Electronics, Mechanics, Design Control Process, Design Verification, Medical Standards (IEC 60601, ISO 13485, FDA 21CFR820, ISO 14971, MDR, GMP, GDP), Risk Management, CAPA, Regulatory Compliance
Preferred skills
Electronics obsolescence, Windchill, Altium, Solid Works, Statistical methods
Technologies
Windchill, Altium, Solid Works
Responsibilities
Lead and support on-market products with manufacturing, regulatory, and quality activities; Manage multiple projects for timely completion; Own and support Design Control Process documentation; Design, plan, integrate, execute, and document tests in compliance with regulatory requirements; Collaborate with Manufacturing Engineering and Production; Support product development activities on the full life-cycle of medical devices; Participate in internal and external audits.
Seniority
Senior, hands-on IC