Systems Verification Engineer

About the role

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.

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' needs 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

• 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
• 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
• Able 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
• Able to work with human blood or blood products, with strong lab benchwork skills and meticulous sample handling and prep

Qualifications

• MS or Ph.D. degree in Immunology, Cell Biology, Engineering or in a related discipline
• 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