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US_System Engineer II/III

Company: TalentBurst, Inc.
Location: Pleasanton
Posted on: January 25, 2023

Job Description:

Industry: Biotechnology
Job Title: System Engineer II/III
Location: Pleasanton, CA - -94588
Duration: 06 -Months with possibility of extension

There are 2 openings for this position. One opening for level II and one opening for Level III. Candidates are required to work onsite full-time. This is a replacement for the previous posting ROCGJP00020336. Please ensure that the position your candidate is applying for is clearly stated at the top of their resume.

ESSENTIAL FUNCTIONS:


  • Develops and deploys a wide range of technologies, including sample extraction, library preparation, sequencing, and analysis.
  • Performs integration testing of system components and assesses performance against system-level product requirements.
  • Participates in managing the total product development lifecycle spanning from product concept to launch.
  • Creates and maintains design artifacts in Design History Files.
  • Organizes, writes, and executes test cases for requirement verification. Ensures complete and comprehensive coverage of requirements in the test campaign.
  • Develops and manages system-level product requirements and traceability analysis.
  • Performs product risk management activities using tools such as Hazard Analysis or Failure Modes and Effects Analysis (FMEA).
  • Updates work progress in collaboration tools (Jira, Confluence, -Kanban, Slack)
  • 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)
  • Assesses results for applicability, validity, and conformance to Product Requirements
  • Works independently with general management direction to drive product development and collaborates to identify opportunities for continuous process improvement.
  • Maintains compliance as required by regulatory bodies and the company's quality system.
  • Work closely with internal stakeholders to understand and resolve product performance issues.

    MINIMUM QUALIFICATIONS:
    Level II


    • Bachelor's degree in Chemistry, Biology, Biomedical Engineering, System engineering or related disciplines. Advanced degree preferred.
    • Required BS or equivalent with 2-3 years related experience
    • Hands-on experience with next generation sequencing platforms and/or robotic liquid handlers

      Level III


      • Required BS, MS or equivalent experience in Biomedical Engineering, -Bioinformatics, Computer Science, Biological Science, or related field with thorough technical knowledge and leadership ability
      • Required BS or equivalent with 5+ years related experience or MS with 4+ years related experience; preferred MS with 6+ years related experience


        Preferred Experience:


        • Experience working with IVD medical device systems.
        • Experience integrating components into a system.
        • Experience in product risk management, integration and verification testing, and requirements management

Keywords: TalentBurst, Inc., Pleasanton , US_System Engineer II/III, Engineering , Pleasanton, California

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