🚀 Assay Development

MUST HAVE:

--Requirement writing experience in a regulated industry (medical device industry preferred)

--Risk analysis (FMEA) work in an engineering discipline (regulated medical device company preferred)

--Demonstrated knowledge of systems engineering principles, specifically in requirements engineering, tradeoff analysis, risk management, configuration management, and verification and validation.

--Ability to work cross-functionally with many stakeholders, weighing the needs of many stakeholders and coming to an alignment balancing all needs and tradeoffs

IDEAL

--Assay development experience - particularly with cytology specimens

--Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart.

--Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities