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