BD (Becton, Dickinson and Company) Staff Systems Verification Engineer in San Jose, California
Job Description Summary
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 team. As a highly trusted individual operating with minimal supervision, this individual is required to use sound judgment, think independently, and act decisively.
The Staff Systems Verification Engineer will be responsible for defining, designing, and executing system verification activities throughout all phases of the product development process for cellular analysis systems for research and clinical applications.
The Staff Verification Engineer will lead, provide technical supervision, and guiding senior-level engineering personnel; solving varied technical/scientific problems; and generating and reviewing designs for technical accuracy, completeness and appropriateness in light of objectives, budget, and schedule.
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 Staff 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 Staff Systems Verification 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 Staff Systems Verification 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. This includes the development and execution of formal protocols, analysis and interpretation of results, and
In addition, the Staff Systems Verification 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.
Education and Experience:
Minimum of a Bachelor’s Degree in an engineering, technology, or science field with a minimum of 8 years relevant experience or a combination of equivalent education and experience.
Minimum of 8 years in performing and providing technical direction for the development, engineering, interfacing, integration, and testing of complex hardware/software systems
Typically requires a minimum of 8 years leading, providing technical supervision, and guiding senior-level engineering personnel; solving varied technical/scientific problems; and generating and reviewing designs for technical accuracy, completeness and appropriateness in light of objectives, budget, and schedule.
Experience in many various system design and development to include: articulating the architectural vision; conceptualizing and experimenting with alternative architectural approaches; creating models and component and interface specifications documents and validating the architecture against requirements and assumptions.
Minimum of 8 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
Provides input on R&D business and technical strategies, goals, and objectives.
Establish departmental tasks and priorities necessary to meet program objectives, including monitoring cost/schedule/staffing performance to plan.
Participates in subsystem Design and Technical Reviews to ensure customers’ needs are satisfied and subsystem designs are consistent with systems-level requirements.
Promotes system-wide thinking in a team environment where some members are from other functional groups.
Work with marketing, program management, and customers to capture market feedback and develop innovative systems solutions to current and future customer needs.
Performs system-level architecture simulation and analysis to evaluate design trade-offs.
( Preferred ) Ph. D in Engineering (e.g. systems, biomedical, electrical, fluidics, optical, biochemical, software), Biostatistics, or Statistics
Knowledge in systems engineering practices, experience in developing good requirements
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
Primary Work LocationUSA CA - San Jose
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