"Alerted.org

Systems Engineer - Assay Development ROCGJP00039030 * Hourly pay: $40-$45/hr * Worksite: Leading biotechnology company (Tucson, AZ 85755 - Hybrid, Must be 3+ days in office) * W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL * 40 hours/week, 11 Month Assignment A leading biotechnology company is seeking a Systems Engineer - Assay Development. The successful candidate will drive requirements definition, risk management, and verification & validation practices in projects. Systems Engineer - Assay Development 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. Systems Engineer - Assay Development Qualifications: * 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. * 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. Shift: * Monday to Friday, 8 am to 5 pm.