Job Title: Systems Verification & Validation Engineer (Exp in Product Development And Design Control)

Location: San Jose, CA

Duration: 12+ Months

Client: Medical Device Company

Job Category: Engineering

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s
Work hours: 40hr/ week Onsite, 8am - 5pm

Must Haves
• 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

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.
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
• 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.
• 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.
• 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.
• 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

At Client Biosciences, our purpose is to help all people live healthy lives. We are a world leader bringing innovative tools to research and clinical laboratories in basic research, drug discovery and development, biopharmaceutical production and disease management. We develop technology that enables faster diagnosis and better clinical outcomes.