Principal Systems Engineer
Core
Lead systems engineering for complex electrical-mechanical medical devices, specifically negative pressure wound therapy pumps, ensuring integration of mechanical, electronic, and firmware elements.
Role type
Principal Systems Engineer (Medical Devices)
Builds
Electrical-mechanical pump systems for wound care technology
Domain
Medical Devices / Healthcare Technology
Required skills
Systems engineering, requirements management, traceability, verification and validation, multidisciplinary team coordination, technical risk assessment, component obsolescence management, regulatory standards knowledge (ISO 14971, IEC 60601), root cause analysis
Preferred skills
Active medical device development, negative pressure wound therapy, pump technologies, embedded control systems, Design History Files, post-market improvements
Technologies
Electrical-mechanical systems, firmware, sensors, actuators, power systems
Responsibilities
Lead systems engineering activities across development and lifecycle management; Translate user and clinical needs into system requirements; Coordinate mechanical, electronic, and firmware specialists; Develop and maintain system architectures and technical documentation; Establish traceability from user needs through design verification; Lead system design reviews and technical risk assessments; Manage technical changes and component substitutions; Support supplier selection and component qualification; Contribute to regulatory submissions and Design History Files.
Seniority
Principal, hands-on IC with strategic oversight