Systems Integration Engineer II

Freenome•Brisbane, CA

10d•Onsite

About The Position

About this opportunity: Freenome is hiring a Systems Integration Engineer to participate in a cross-functional team and contribute to the development of next generation NGS assays/products for early cancer detection. You will work in a Product Development team of world-class Scientists and Engineers focused on delivering Freenome’s IVD assay portfolio. If you are passionate about deploying the power of NGS-based diagnostics in clinical care, and take pride in providing technical expertise to a growing team of Systems Integration Engineers, making a significant individual impact, we would love to speak with you! As part of a dynamic, flexible company you will be adapting to rapid technological progress and change, and help the team building the platform do the same. The role reports to the Senior Manager, Development & Scientific Operations. This role will be an onsite role based in our Brisbane, California headquarters.

Requirements

Bachelor’s degree or Master’s degree with 2+ years of relevant work experience OR Doctoral degree
Education or equivalent experience in a relevant field such as Biology, Biochemistry, Bioengineering, Biomedical Engineering, etc.
Previous experience as a hands-on engineer, scientist, or product developer (e.g. System Integration Scientist / Engineer, System Development Scientist / Engineer, or related occupation)
Experience with developing and integrating complex instrumentation systems which incorporate optical, mechanical, thermal, and firmware components
Data analysis expertise and experience with various data analysis software packages
Well-developed mathematical and statistical analysis skills. (i.e., JMP, R, DOE)
Knowledge of SQL, Python, R or other programming languages highly desired
Knowledge of a broad range of principles of biology, chemistry and physics, such as spectroscopic techniques, organic chemistry, electromagnetic theory, and thermodynamics
Strong integration analytical, process validation and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems
Working knowledge of design of experiments, interpretation of test results, failure investigation and root cause failure analysis
Excellent communication skills, verbal and written
Demonstrated ability to understand and comply with applicable FDA regulations and company operating procedures, processes, policies and tasks
Work as part of a team to guarantee high quality of technical and design control documentation in alignment with Freenome’s Quality requirements

Responsibilities

Execute end-to-end assay workflows using industry-leading automation platforms to support development of Freenome’s next generation diagnostic products
Hands-on design and execution of complex test methods to assess hardware and system performance per Design Input Requirements
Evaluate resulting system performance, speed and throughput, and identify root causes for system-level issues and failures
Contribute to dFMEA, pFMEA, risk management, hazard assessment, and design review sessions with Engineering, Automation, and Systems Integration teams
Analyze outputs and identify HW, FW, and SW mitigating solutions to implement adequate risk control measures
Identify and steward Systems Integration initiatives to enable achievement of critical path project milestones/timelines
Support the system evaluation process through development and execution of system level test plans and protocols, including data analysis, interpretation and communication of results and their impact through written reports, design reviews, and interactive discussions
Apply sophisticated analytical problem solving skills to reagent and system integration issues to identify critical performance factors for assay development
Apply broad scientific, technical or professional concepts in accordance with area(s) objectives
Assess results for applicability, validity, and conformance to Product Requirements
Write and manage requirements as part of Project Team.
Create and maintain design documentation in Design History Files