Senior Systems Verification Engineer

1 day ago


San Jose, California, United States MILLENNIUMSOFT Full time
Job Title: Senior Systems Verification Engineer

At MillenniumSoft, we are seeking a highly skilled Senior Systems Verification Engineer to join our cross-disciplinary product development team. As a key member of our team, you will be responsible for defining, designing, and executing verification activities in the product development process for our instrument systems.

Key Responsibilities:
  • Lead the definition, design, and execution of system verification activities on instrument projects.
  • Determine strategy for testing product requirements, including how requirements will be tested, sample size, resource and material needs.
  • Develop and write system verification and validation test methods to evaluate product requirements.
  • Act as a liaison between the Program Core Team and Systems Validation and Reliability team.
  • Represent the department on collaborative projects by elevating customer needs and product quality.
  • Exercise independent judgment and apply solution thinking, problem solving, and troubleshooting.
  • Conduct representative sample prep and flow cytometry experiments to test products.
  • Maintain up-to-date knowledge of customer workflows, scientific advancements in flow cytometry, and the competitive landscape.
  • Mentor and support more junior members in understanding systems verification best practices.
  • Escalate top issues by providing clear, well-structured, high-level updates.
Requirements:
  • B.S. in Immunology, Cell Biology, Engineering or related discipline.
  • Minimum of 5 years' experience in systems verification and validation principles or studies while working in biotech, pharma industry, clinical research, or other relevant industry.
  • Experience in product development and design control.
  • Ability to meet technical objectives and solve challenges under conditions of ambiguity and rapid change.
  • Experience training bench-level personnel and leading projects.
  • Excellent listening, written, and oral communication skills.
  • Experience running and trouble-shooting complex optical/mechanical instrumentation.
  • Able to work with human blood or blood products, with strong lab benchwork skills and meticulous sample handling and prep.
Assets:
  • MS or Ph.D. degree in Immunology, Cell Biology, Engineering or in a related discipline.
  • Strong knowledge of flow cytometry applications.
  • Extensive hands-on experience operating and troubleshooting flow cytometry analyzers and/or sorters, with knowledge of flow cytometry instrument platforms, applications and software, and assay panel development.
  • Experience with sample prep and experiment design for multi-parameter flow cytometry applications.
  • Experience working within a regulated medical device industry with knowledge or experience in regulatory submissions.
  • Experience in systems engineer practices.


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