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To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate and capable Systems Verification Engineer to contribute to a cross-disciplinary product development team. The 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.
Job Responsibility:
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.
Requirements:
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
Experience working within a regulated medical device industry with knowledge or experience in regulatory submissions
Experience in systems engineer practices
B.S. in Immunology, Cell Biology, Engineering or related discipline
MS or Ph.D. degree in Immunology, Cell Biology, Engineering or in a related discipline.