Systems Engineer
Core
Design, development, sustaining, and quality processes for wearable medical devices (insulin pumps) used by patients globally.
Role type
Systems Engineer (Medical Device R&D)
Builds
Wearable pump technology and insulin delivery systems
Domain
Medical Devices / Biomedical Engineering
Required skills
Systems engineering, failure analysis, risk assessment, root cause investigation, design documentation, technical writing, lab equipment operation, system integration, verification testing
Preferred skills
Software as a Medical Device (SaMD), cloud systems (AWS/Azure), IoT/connected systems, data analysis (MatLAB/Minitab/PowerBI), software lifecycle tools (Jira/Helix/Bamboo/Bitbucket/Polarion), medical device regulations
Technologies
AWS, Azure, Jira, Helix, Bamboo, Bitbucket, Polarion, MatLAB, Minitab, PowerBI
Responsibilities
Troubleshoot design issues and lead root cause investigations; collaborate cross-functionally with support, software, and quality teams; manage post-market initiatives and field investigations; design and execute feasibility and verification tests; author engineering build requests and design protocols; participate in product design reviews and triage sessions.
Seniority
Mid-level (2+ years experience)