Job Title: Systems Verification Scientist II (Exp In Product Development & 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

Must Haves
• A minimum of a Bachelor’s Degree in Biology, Immunology, Biomedical Engineering, or related fields.
• A minimum of 2 years of experience in product development with knowledge of design control elements
• Basic knowledge of the purpose of System Verification and Validation
• Basic understanding on how to operate and trouble-shoot a Flow Cytometer Instrument
• Ability to translate verbal and/or visual instructions into written instructions
• Experience following signed protocols, standard operating procedures, and adhering to quality/ regulatory requirements
• Can make minor modifications to existing protocols
• Can work independently after getting hands on training on protocol execution

Job Summary
Client Biosciences is seeking a passionate and capable systems verification scientist to contribute to a cross-disciplinary product development team, and to develop method improvements that drive greater efficiency and productivity of the Systems Verification and Validation team. The Systems Verification Scientist II is a hands-on testing and problem-solving role that will involve conducting experiments using flow cytometry.

Responsibilities
- The Systems Verification Scientist II will work closely with Senior Systems Verification Scientist or Engineer and the product development team to ensure product design meets product requirements on Client flow cytometry products, with emphasis on assessing the features to meet the needs of the customer.
- He/She applies engineering, statistics, and scientific theory to measure and quantify performance of BD cell analysis products. He/She will conduct experiments to assess system performance. This may include the planning, writing and execution of system verification and validation protocols, analysis and interpretation of results, and communication of results and their impact to the project through written reports, design reviews, and interactive discussions.
- The Systems Verification Scientist II may be called upon to lead small to medium sized projects or initiatives, including generation of project plans, development of test strategies that balance risk and business objectives
- The Systems Verification Scientist II may be responsible for translating product requirements to system verification test protocols.
- He/She is comfortable asking questions, raising concerns, and engaging in technical dialog with engineers and project stakeholders.
- He/She will regularly exercise independent judgment and apply systems thinking, problem solving, debugging, and troubleshooting to generate innovative ideas to improve BD products or processes.
- The individual shall operate within BD design control, quality, and safety requirements, and promote a safe working environment.

Qualifications
The successful candidate will possess:
• A minimum of a Bachelor’s Degree in Biology, Immunology, Biomedical Engineering, or related fields.
• A minimum of 2 years of experience in product development with knowledge of design control elements
• Basic knowledge of the purpose of System Verification and Validation
• Basic understanding on how to operate and trouble-shoot a Flow Cytometer Instrument
• Ability to translate verbal and/or visual instructions into written instructions
• Ability to quickly grasp the functionality and interdependencies of complex multidisciplinary systems, to include lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.
• Ability to understand the broader impact of design features, testing methods, and test results in the context of the user, customer, regulatory guidelines, and to the marketability of the product.
• Apply systematic troubleshooting and debugging skills, practice in “systems thinking” problem solving approaches
• Strong interpersonal skills
• Excellent written and oral communication skills
• Attention to detail
• Proficient in data extraction, manipulation, interpretation, and presentation
• Ability to prepare and process biological samples in a wet-lab Biosafety Level 2 Laboratory

Desired:
• MS or Ph.D. degree in Biology, Immunology, Biomedical Engineering or in a related discipline.
• Strong knowledge of flow cytometry applications and assay panel development.
• Experience working within a regulated medical device industry
• Experience in statistics, design of experiments, calculating sample sizes and estimating statistical power of study designs.