Systems Engineer - Assay Development

Avispa Technology•Tucson, AZ

6d•$40 - $45•Hybrid

About The Position

A leading biotechnology company is seeking a Systems Engineer - Assay Development . T he successful candidate will drive requirements definition, risk management, and verification & validation practices in projects.

Requirements

3-5 years of experience.
Bachelor’s degree in Engineering.
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.

Nice To Haves

Assay development experience, particularly with cytology specimens, is preferred.
Prior experience in RETINA (Requirements & Test Integration Application) and with LucidSpark/LucidChart is preferred.
Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities is preferred.

Responsibilities

Define requirements, design system architectures, and implement solutions to meet IVD standards.
Take ownership of project deliverables and facilitate the decision-making process with well-considered tradeoffs.