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System Engineer

San Jose Metro Area, CA

Posted: 07/09/2019 Job Type: Scientific Job Number: JN -072019-25190

Duties:

The System Engineer I 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.

The employee's primary responsibilities will be

  • Requirements Management & Analysis - Work with cross-functional teams to determine and document appropriate design requirements
  • Design Verification - Develops test plans, writes test cases, and implements and executes automated tests to verify the hardware, software and system performance
  • Contributes to the Risk Management process, Configuration Management and documentation under design control procedures
  • Works under general supervision, to conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understandingin the laboratory.
  • The employee will also review and edit project documentation (for example, system test cases and reports). Candidate should be proficient in executing and documenting test results in a regulated environment.
  • 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
Skills:
Ability to perform instrument/software/system feasibility and validation testing according to instructions from RSS technical staff. Laboratory work experience in the medical device industry or in a laboratory using robotic instruments. Experience with testing instrument software and hardware. Familiarity with running clinical diagnostic instruments. Knowledge of NGS workflows and data analysis is desirable. Experience with NGS systems development is a plus. Assists in system troubleshooting issues, and follow-up, as required. Performs ad-hoc testing on software releases during product development. Drafts and manages test case procedures. Also assists in the review of test case procedures. Executes test cases, records test results, and compiles associated documentation. Presents findings at group meetings, as required. 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.

Education:
Bachelor's degree in Biomedical Engineering or related field, or equivalent combination of education and work-related experience. 1-3 years relevant hardware and/or software testing experience or equivalent combination of education and/or work related experience. Experience in or knowledge of product development strongly desired. High competence, with a track record of strong problem solving. Organized and detail-oriented, with demonstrated analytical skills. Experience working on the development of medical devices under design control processes, experimental design, versatile laboratory practice, data analysis, and data and concept presentation.
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