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Sr. Systems Verification & Validation Engineer

Apply Now Job ID R-26689 Date posted 01/13/2018

Job Description Summary

Job Description

At BD 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. 


To ensure that our cell analysis products deliver outstanding performance and exceed our customers’ expectations, BD Biosciences is seeking a passionate and capable systems test engineer 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.  As a highly trusted individual operating with minimal supervision, this individual is required to use sound judgment, think independently, and act decisively.

Job Responsibilities:

The Sr. Systems Verification and Validation Engineer will be responsible for defining, designing, and executing system verification and validation activities throughout all phases of the product development process for cellular analysis systems for research and clinical applications. This includes the development and execution of formal protocols, and the analysis, interpretation, and documentation of results.

He/she will work closely with systems engineers, marketing, and the product development team to enable the successful application and integration of new technologies, including hardware, software, and reagents in BD flow cytometry products.  The Senior Engineer influences the product design by contributing innovative ideas, assessing the suitability of design architectures and features to meet the needs of the customer, and ensuring the quality of the product through rigorous testing.  In addition, he/she participates in customer engagement activities to thoroughly understand customer needs, and assist product development teams in translate these customer needs to measurable technical specification and product requirements.

The Senior Engineer applies engineering and technical problem solving expertise to the hands-on application of and performance measurement of flow cytometry systems.  He/she will design, plan, and conduct experiments to assess the technical capability, feasibility, and performance of sub-systems and systems.  He/she keeps abreast of technology advancements, and leads initiatives to drive more reliable, efficient, and effective verification testing, such as automated test fixtures, simulation and analysis capabilities, while satisfying the expectations of regulatory stakeholders.

The Senior Systems Verification and Validation Engineer will use good judgment in leading projects or initiatives of complex scope and/or direct teams of 10 or more contributors.  The individual understands and communicates the broader impact of design features, test methodologies and strategies, and results to the end-user, customer and to the marketability of the product. He/she understands and appreciates the customer need, and acts as a customer advocate to product development teams to ensure that the right product is built.

In addition, the Senior Engineer will engage in hardware/software integration testing, performance characterization, requirements analysis, test design, test execution, defect and customer complaint root cause investigations, and risk and hazard analysis.  He/she is an excellent systematic troubleshooter, combining a thorough understanding of the product’s subsystems - how they function and interact with each other – with knowledge of customer needs and workflows to solve problems. 

He/she may be called upon to represent the voice of the customer to product developers, and assist with translating the customer needs to product requirements, specifications, and test methods to ensure needs are met.  The individual understands and communicates the broader impact of design features, test methods, and test results to the end-user, customer, regulator, and to the marketability of the product.

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.

Minimum Qualifications:

The successful candidate will possess:

  • Requires a minimum of a Bachelor’s Degree in an engineering, technology, or science field with a minimum of 5 years' relevant experience or a combination of equivalent education and experience.
  • Minimum of 5 years' experience in product development, instrumentation development, medical devices, test engineering, or other relevant industry experience
  • Demonstrated knowledge and application of fundamental engineering concepts
  • 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.
  • Apply systematic troubleshooting and debugging skills, practice in “systems thinking” problem solving approaches
  • Strong interpersonal skills
  • Excellent written and oral communication skills
  • Ability to prepare and process biological samples in a wet-lab Biosafety Level 2 Laboratory
  • Ability to apply careful attention to detail
  • Ability to understand the broader impact of design features, testing methods, and test results to the user, customer, regulator, and to the marketability of the product.
  • Ability to critically evaluate proposed study designs
  • Proficient in data extraction, manipulation, and interpretation

Assets:

  • M.S. in Engineering (e.g. systems, biomedical, electrical, fluidics, optical, biochemical, software), Biostatistics, or Statistics
  • Knowledge in systems engineering practices, experience in developing good requirements
  • Knowledge of DFSS (Design for Six Sigma)
  • Experience in product development process and design control
  • Experience working within a regulated medical device industry
  • Knowledge of immunology and/or experience in assay development or application
  • Experience in the cultivation, processing, or handling of cells
  • Experience working in a Biosafety Level 2 Laboratory
  • Knowledge of flow cytometry instrumentation and/or flow cytometry applications
  • Knowledge or experience in FDA submissions
  • Knowledge or experience interpreting CLSI guidelines
  • Experience in statistics, design of experiments, calculating sample sizes and estimating statistical power of study designs. 
  • Experience using MATLAB, SAS, JMP, R, MiniTab, or LabVIEW for scripting, data analysis, or automation.

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Primary Work Location

USA CA - San Jose

Additional Locations

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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com