Industry: Medical Devices
Title: Systems Engineer - Assay Development
Job ID: ROCGJP00037998
Location: Tucson, AZ Hybrid (Minimum 3 days in office)
Duration: 12+ months contract (+Possibility of extension)
*W2 acceptable only
Job Description:
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
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