Staff Clinical Engineer
Core
Translate clinical observations and study results into technical insights to inform the design, safety, and effectiveness of a wearable patch defibrillator for patients at risk of sudden cardiac arrest.
Role type
Staff Clinical Engineer (Medical Device)
Builds
Clinical-grade wearable defibrillator patch and related digital health solutions
Domain
Medical device / Digital health / Cardiology
Required skills
Clinical engineering, Biomedical engineering, Human factors engineering, Medical device product development, Verification and validation, Risk management, Test protocol development, Data analysis, Technical documentation, Cross-functional collaboration
Preferred skills
GLP study experience, Human factors/usability testing for medical devices, Regulatory submission support, Design controls knowledge
Technologies
Wearable hardware, Clinical testing models, Study protocols
Responsibilities
Collaborate with engineering, design, and regulatory teams to support product development; Identify and document clinical needs and product requirements; Act as clinical SME for risk analysis and usability assessments; Develop and execute test methods and study protocols including volunteer wear studies and human factors validation; Collect, analyze, and interpret study data to contribute to technical reports; Troubleshoot clinical and technical issues; Develop and maintain study documentation and training materials; Support continuous improvement of clinical engineering processes.
Seniority
Staff, hands-on IC with strategic input