iRhythm is looking to address unmet clinical needs in cardiac health by developing and improving its SaaS, Machine Learning, Big Data, and Mobile technologies.
Requirements
- Understanding of basic statistics and proficiency with data analysis using Python (e.g. pandas) or R
- Experience with developing technical product/software requirements
- Experience with FDA 21 CFR part 820 and IEC standards 62304, 14971 and 62366
- Experience with failure mode analysis (dFMEA, uFMEA), risk management and hazard analysis
- Experience with human factors and usability engineering processes
- Proficiency in Linux/Unix/Windows environments, AWS
- Software development experience with one or more of Python, Java, C-Sharp, or C/C++
Responsibilities
- 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 and facilitate V&V with the Software QA team
- Lead root cause investigations and providing solutions for operational issues related to software
- Ownership of software operational performance monitoring and alerting
- Rapidly prototype software and/or write scripts for research and development needs
- Participate and lead risk management, human factor/usability and hazard analysis activities
Other
- Are a quality-minded individual with ability to go detail-oriented while having the big picture in mind
- Enjoy investigative and troubleshooting processes using your excellent analytical and problem solving skills, along with a strong sense of urgency
- Are self-motivated and demonstrates initiative in helping others
- Have effective presentation and interpersonal skills
- BA/BS in science or technical field; Advanced engineering degree desired
