Systems Engineer - Assay Development

--M-F, 8am to 5pm
--Hybrid (Minimum 3 days in office)
--3-5 years of experience

As a member of our R&D team, the Systems Engineer will drive requirements definition, risk management, and verification & validation practices in projects. This includes defining requirements, designing system architectures, and implementing solutions to meet IVD standards. This individual will take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.

Skill Set Requirements

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

Bachelor s degree in Engineering is required