Sr System Engineer, Sequencing

United States, California, Pleasanton

The Senior System Engineer at 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.

 

Experience and Responsibilities:

  • Expertise in RUO or IVD instrument design and development is essential.
  • Nucleic acid based diagnostics technology background and next-generation sequencing experience are highly desirable. Other system development experience in complex clinical diagnostic development environments is a plus.
  • Significant experience with all phases of technology development is highly desirable.
  • Specific experience in Requirements Management and Analysis as well as Design Verification process for diagnostic systems is essential.
  • Knowledge of all phases of NGS workflows and data analysis is desirable. Experience with NGS systems development is a plus.
  • Knowledge of Risk Analysis methods, Reliability Engineering, Design Transfer activities for product manufacturing, Regulatory Compliance evaluation, and medical device safety certification is desirable.
  • Previous experience working with or managing relationships with external OEM vendors.
  • The individual responsibilities are:
    • Designs, plans and executes assigned Systems Development related experiments/projects utilizing established and innovative procedures, and applying scientific knowledge and accumulated experience to complete projects.
    • Contributes to the definition and timely achievement of overall project goals. Makes recommendations, and when appropriate, acts independently to resolve scientific problems encountered during experimental procedures to improve productivity of results.
    • Ensures activities are consistent with project critical path, and responds appropriately to changing priorities.
    • Oversees Systems Development aspects of project tasks to ensure completion within expected parameters and period.
    • Applies specialized knowledge to a broad range of System problems. Leads technical activities in an area of specialty.
    • Communicates results to management via written reports and oral presentations.
    • Applies broad scientific, technical or professional concepts in accordance with area(s) objectives.
    • Assesses results for applicability, validity, and conformance to Product Requirements. Writes and manages requirements as part of Project Team.
    • Works on a wide range of problems where original contributions are required. Creative, imaginative thinking is required. Works independently with general management direction. Work is reviewed in detail over a specific time frame.
    • Activities are planned jointly with management to develop objectives, schedules and budgets. Progress reported at appropriate intervals.
    • May directly supervise technical personnel. Provides technical advice to technical community.
    • Provides technical advice/guidance to junior engineering staff, and serves as a role model.