Eng II, Systems C&S
Core
Design and development of electro-mechanical medical device solutions for respiratory and cardiac care, ensuring compliance with global safety and regulatory standards.
Role type
Senior IC systems engineer (medical device)
Builds
Airway clearance, cardiology, and patient monitoring products
Domain
Medical device industry, regulatory compliance, electro-mechanical systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
System engineering, risk management (ISO 14971), compliance testing, technical documentation, integration management, regulatory strategy (FDA/MDR/CE), usability engineering, QFD, DFX
Preferred skills
Experience with DOORS, IEC 60601-1, IEC 62304, EMI/EMC, REACH, ROHS, Biocompatibility
Technologies
DOORS, Excel, IEC 60601-1, IEC 62304, FDA regulations, MDR
Responsibilities
Define customer needs and safety requirements for product solutions; execute compliance testing to meet cost, quality, and schedule targets; manage system-level requirements decomposition; lead integration efforts and resolve complex technical issues; obtain and maintain third-party product certifications and type approvals; support Notified Body audits and create technical files for CE marking; communicate codes and standards requirements to R&D teams; collaborate with QA/RA for global product registration.
Seniority
Mid-level IC (3-8 years experience)