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System Engineer II/III
Location: US-CA-Pleasanton
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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
Best Regards, Dawar Consulting Inc.
Dawar Consulting
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