Job Description

JOB TYPE: Contract JOB LENGTH: 1 Year (Renewable) COMPENSATION: Negotiable JOB ID: 36610 WORK HOURS: 9:00 AM- 5:00 PM Monday through Friday

ONSITE PRIMARY DUTIES INCLUDE: • 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 customers need 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 EDUCATION AND EXPERIENCE: • 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  

Company Description

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