Systems Engineer - Assay Development

Systems Engineer - Assay Development
ROCGJP

• 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.

• 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.

• 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 Lucid Spark/Lucid Chart is preferred.
• Excellent organizational skills, with the ability to efficiently evaluate, prioritize, and handle multiple projects and priorities is preferred.

• Monday to Friday, 8 am to 5 pm.