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System Engineer II/III
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Our client, a world leader in Pharmaceuticals and In- Vitro Diagnostics (IVD) tools, is seeking a "Senior System Engineer" who will be part of the Systems Development team focusing on the development of a cutting edge next-generation sequencing (NGS) system for IVD assays and applications. The candidate is expected to be a hands-on contributor in the feasibility, development, and integration phases of end-to-end NGS solutions.
Job Title: System Engineer II/III
Duration: Long Term Contract
Location: Pleasanton, CA (Onsite)
Roles & Responsibilities:
  • 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.
  • 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.
  • Education, Skills & Experience:
    Level II
    • Bachelor's degree in Chemistry, Biology, Biomedical Engineering, System engineering or related disciplines with 2-3 years of experience. Advanced degree preferred
    • Hands-on experience with next generation sequencing platforms and/or robotic liquid handlers
    Level III
    • Required BS with 5+ years related experience Or MS with 4+ years related experience
      or equivalent experience in Biomedical Engineering, Bioinformatics, Computer Science, Biological Science, or related field with thorough technical knowledge and leadership ability. Preferred MS 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
    Please respond with updated resume & contact information to
    Best Regards,
    Dawar Consulting Inc.

    Dawar Consulting

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