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Staff Engineer I, Clinical System Verification

Company: BD
Location: San Jose
Posted on: January 15, 2022

Job Description:

Job Description SummaryJob DescriptionBe part of something bigger!BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.Job SummaryAt 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 direction, this individual is required to use sound judgment, think independently, and act decisively.ResponsibilitiesThe 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 clinical applications.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.Establishes departmental tasks and priorities necessary to meet program objectives, including monitoring cost/schedule/staffing performance to plan.This individual acts as conduit between core team and extended teams. Facilitates Design and Technical Reviews to ensure customers' needs are satisfied and design outputs are consistent with systems-level requirements.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 and automated sample preparation robotic systems.Work closely with regulatory and quality partners on regulatory submissions.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 thorough testing.Applies engineering and technical problem solving expertise to the hands-on application of and performance measurement of flow cytometry systems.Design, plan, and conduct experiments to assess the technical capability, feasibility, and performance of sub-systems and systems.Stays ahead 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 partners.Use good judgment in leading projects or initiatives of sophisticated scope and/or direct teams of 10 or more contributors.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.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.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.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.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.QualificationsTypically requires a minimum of a Bachelor's Degree in an engineering, technology, or science field with a minimum of 8 years proven experience or a combination of equivalent education and experience.Minimum of 8 years' experience in product development, instrumentation development, medical devices, test engineering, systematic troubleshooting or other relevant industry experienceKnowledge or experience in FDA submissions. PMP and/or RAC certification is a plusExperience being a core team member with the ability to think strategically and creatively in leading project teams through obstacles.Ability to collaborate with regulatory, quality and program management on drafting reports and justifications for regulatory submissionsExperience leading team of scientists/engineers, global 3rd party resources and design partners to ensure success of functional deliverablesAbility to adapt to changing circumstances and change course with the needs of the business.Effective presentation and meeting skills within all levels of the organization and with a wide variety of external/internal colleagues and collaboratorsAbility to quickly grasp the functionality and interdependencies of sophisticated multidisciplinary systems, to include lasers, optics, fluidics, electro-mechanical devices, software, algorithms, biological samples, and biochemistry.Must have a strong sense of accountability and learning agility.Excellent written and oral communication skillsAbility to prepare and process biological samples in a wet-lab Biosafety Level 2 LaboratoryAbility to apply careful attention to detailProficient in data extraction, manipulation, and interpretationDesired:Ph.D in Engineering, Biostatistics, or StatisticsKnowledge in systems engineering practices, experience in developing good requirementsExperience in product development process and design controlExperience working within a regulated medical device industryKnowledge of immunology and/or experience in assay development or applicationExperience in the cultivation, processing, or handling of cellsKnowledge of flow cytometry instrumentation and/or flow cytometry applicationsKnowledge or experience interpreting CLSI guidelinesExperience 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 automatClick on Apply if this sounds like you!Employment at BD is contingent upon the Company's receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why join us?A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life's purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program "-- - - which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components "-- - - is designed to support the varying needs of our diverse and global associates.To learn more about BD visit 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, or any other protected status.Primary Work LocationUSA CA - San JoseAdditional LocationsWork Shift

Keywords: BD, San Jose , Staff Engineer I, Clinical System Verification, Healthcare , San Jose, California

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