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System Engineer II
Ref No.: 18-12994
Location: Pleasanton, California
The System Engineer II in Roche Sequencing Solutions will be part of the system development team focusing on the development of a cutting edge next-generation sequencing (NGS) system for RUO & IVD applications.
Works under general supervision, to conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understanding
Work with cross-functional teams to determine and document appropriate design requirements
Contributes to the Risk Management process and documentation under design control procedures
Makes recommendations to resolve problems encountered during experimental procedures
Assumes responsibility for the accuracy, quality, and timeliness of experimental results
Summarizes experimental results, and reviews conclusions with supervisor/project leader
Communicates results of experiments in the form of reports and presentations
Keeps supervisor/project leader informed of project status, particularly of significant findings and results in critical problem areas. Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g. OSHA)
Oversees these aspects of project work to ensure completion within the expected parameters and time frame
Communicates results to management via written reports and oral presentations
Work is typically complex and of considerable scope and therefore requires application of technical principles, tools and knowledge gained from previous work experience
Assesses results for applicability, validity, and conformance to Product Requirements
Works on a wide range of problems where original contributions are required. Creative, imaginative thinking is required.
Develops test plans, writes test cases, and implements and executes automated tests to verify the hardware, software and system performance.
Hands-on with a strong instrument/platform development background, the candidate will be asked to troubleshoot systems, identify opportunities for quality improvements, provide root causes of complex HW-SW interaction problems, and communicate test results and corrective recommendations to the team. He or she will work closely with internal design teams to understand and resolve product performance issues.
Activities are planned jointly with management to develop objectives, schedules and budgets.

Experience in RUO or IVD product design and development is essential.
Specific experience in Requirements Management and Analysis as well as Design Verification process for biomedical systems is highly desirable.
Knowledge of Risk Analysis methods, Reliability Engineering, Design Transfer activities for product manufacturing is desirable.
Experience with all phases of technology development is highly desirable.
Nucleic acid based technology background and next-generation sequencing experience are highly desirable. Other system and / or software development experience in complex diagnostic development environments is a plus.
Knowledge of NGS workflows and data analysis is desirable. Experience with NGS systems development is a plus.