Senior Systems Verification Engineer
3 weeks ago
Job Title – Senior Systems Verification Engineer (Must Have Flow Cytometry)
Location - San Jose, CA
Duration – 12+ Months Contract
Total Hours/week - 40.00
1st Shift
Description:
Senior Systems Verification Engineer
Must include answers to these questions:
1. What is your motivation for applying to this position?
2. What are your career goals?
3. What is your experience with diagnostic instrumentation or complex systems that include optics, assays, electro-mechanical components, and software?
4. What has been your experience working in a lab environment testing and/or verifying systems?
5. Describe your work experience in product development.
6. Describe the basic operations of a flow cytometry instrument.
To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate and capable Senior Systems Verification Engineer to contribute to a cross-disciplinary product development team.
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
Minimum Qualifications:
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
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