Senior Systems Engineer
MrBeastFull Time
Senior (5 to 8 years)
Candidates are required to have 5+ years of system/software engineering experience in the Healthcare, Medical Device, or other Regulated software industry, along with an understanding of basic statistics and proficiency with data analysis using Python (e.g. pandas) or R. Experience with developing technical product/software requirements, FDA 21 CFR part 820 and IEC standards 62304, 14971 and 62366, failure mode analysis (dFMEA, uFMEA), risk management and hazard analysis, and human factors and usability engineering processes is also necessary. Proficiency in Linux/Unix/Windows environments and AWS is required, and a BA/BS in science or technical field, or an advanced engineering degree, is desired.
As a Senior Systems Engineer I, the candidate will work with engineering and cross-functional stakeholders to research, define, and write technical requirements for software components and systems, perform data analysis to aid product and implementation decisions, plan and perform design history file (DHF) updates, facilitate V&V with the Software QA team, lead root cause investigations and provide solutions for operational issues related to software, own software operational performance monitoring and alerting, rapidly prototype software and write scripts for research and development needs, and participate and lead risk management, human factor/usability and hazard analysis activities.
Advanced cardiac monitoring solutions provider
iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.