System Engineer - Assay Development

Location: Tucson, AZ

Type: Contract W2; 1 year with a possible extension

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 & validation
• Ability to work cross-functionally with many stakeholders, balancing needs and tradeoffs effectively

Ideal:

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

Education:

• Bachelor's degree in Engineering required

We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs