Systems Engineer (Pharm/IVD)

Software Guidance & Assistance, Inc., (SGA), is searching for a Systems Engineer (Bio Lab/IVD) for a contractassignment with a leading Pharmaceutical client in Pleasanton, CA. The System Integration Engineer II will be part of the system development team focusing on the development of a cutting edge next-generation sequencing (NGS) software, system for IVD assays and applications. Will be part of a team tasked with software integration for automation solutions, as well as systems engineering activities for those automation solutions for the NGS platform. REQUIRED:

• Expertise in all phases of Systems Development in an IVD environment

• Expertise in system verification and validation/requirement management/risk management
• Expertise in any robotic liquid handling instruments such as Hamilton, Tecan, Agilent, etc
• Strong laboratory proficiency and experience with molecular techniques and concepts
• Software background in hardware/software integration including working with software simulators to mimic system integration
• Understanding of agile development practices, including incremental systems development
• Expertise in design and development of Molecular Sample Preparation Automation instruments
• Knowledge of all phases of NGS workflows and data analysis
• Experience using automated (SW) testing tools to drive systems integration
• Experience working with software, robotic liquid handling instruments, and strong laboratory proficiency
• Experience working on development of diagnostic devices under strict IVD design control processes, experimental design, versatile laboratory practice, data analysis, and data and concept presentation