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Job Description Summary
To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate and capable Sr. Systems Verification Engineer to contribute to a cross-disciplinary product development team.
The Sr. Systems Verification Engineer participates in the definition, design, and execution of verification activities in the product development process for BD Biosciences instrument systems. This includes the design of test methods and test strategies, development and execution of verification protocols, analysis and interpretation of results, and communication of results and their impact through written reports, design reviews, and interactive discussions.
Primary job 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 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.
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.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work LocationUSA CA - San Jose
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
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