Systems Engineer - Assay Development

A client of Sharp Decisions is looking for a Systems Engineer - Assay Development (Biomedical/Medical Device) This role is Hybrid in Tucson, AZ, a 12-month contract with possible extension, W2 only.

Position Overview
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

EDUCATION
Bachelor's degree in Engineering is required