Systems Verification Specialist

4 weeks ago


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

At MillenniumSoft, we are seeking a highly skilled Systems Verification Engineer to join our team. As a key member of our product development team, you will be responsible for ensuring the quality and reliability of our medical devices.

Key Responsibilities:

  • Define, design, and execute verification activities for instrument systems
  • Determine testing strategies and develop verification protocols
  • Analyze and interpret results, and communicate findings through written reports and design reviews
  • Collaborate with cross-functional teams to ensure product requirements are met
  • Represent the department on collaborative projects and elevate customer needs and product quality

Requirements:

  • B.S. in Immunology, Cell Biology, Engineering, or related discipline
  • Minimum 5 years' experience in systems verification and validation principles or studies
  • Strong knowledge of flow cytometry applications and experience operating and troubleshooting flow cytometry analyzers and/or sorters
  • Ability to meet technical objectives and solve challenges under conditions of ambiguity and rapid change
  • Excellent listening, written, and oral communication skills

Preferred Qualifications:

  • MS or Ph.D. degree in Immunology, Cell Biology, Engineering, or related discipline
  • Experience in product development and design control
  • Experience working within a regulated medical device industry with knowledge or experience in regulatory submissions


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