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Staff Systems Verification Engineer

Apply Now Job ID R-331529 Date posted 02/22/2019

Job Description Summary

Job Description

This position will be working with the BD Biosciences sustaining team (PaVE) and reporting to the PaVE and RUO Systems Verification Manager.

BD Biosciences (BDB) is seeking a passionate and capable systems verification engineer to play a critical role in sustaining our cell analysis products. The Staff Systems Verification Engineer with work with cross-functional teams to understand the proposed design change(s), assess impact to system level requirements and drive appropriate level of system verification testing. He/she will be a facilitator of best practices to ensure robust design, thorough risk assessment, and cross-functional transparency and alignment. He/she will be an ambassador of customer experience, design quality, and reliability.

Primary duties include the following:

  • The Staff Systems Verification Engineer will be responsible for acting as the central point of contact between the Systems Verification team and the BDB product sustaining team (PaVE).  As such this role will be responsible for providing project management oversight to all sustaining projects that enter PaVE and require systems verification testing.  He/she will assign resources to each project, develop timelines, monitor progress, and escalate issues to relevant stakeholders.

  • In addition to project management, this role will act as a technical resource for guiding project scope, requirements, and verification testing strategy. He/she will be responsible for reviewing and approving all verification test protocols and ensuring these are developed with verification best practices and comply with all applicable regulation. He/she will consult with relevant subject matter experts within the R&D functions (Hardware, Software, Firmware, etc) to ensure all product requirements affected by the proposed change are included in the testing plan.  He/she will review testing plan/strategy with the Verification Manager and request approval.

  • In addition to the above, the Staff Verification Engineer will execute verification test plans.  He/she will design, plan, and conduct experiments to characterize the subsystems or systems to enable verification test design.  He/she will act as a technical resource for other team members in designing characterization experiments. 

  • He/she will apply judgement and experience to ensure the right level of testing is performed.  He/she will evaluate each project to determine whether sub-system or system level testing is required.  He/she will collaborate closely with PaVE management and scrum teams, Operations, Quality, and various functions within R&D to ensure that testing plans are technically feasible, relevant and compliant with applicable regulation.

  • The individual shall operate within BD design control, quality, and safety requirements, and promote a safe working environment.

Minimum Qualifications:

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' experience performing and providing technical direction for the development, engineering, interfacing, integration, and testing of complex hardware/software systems.

  • Demonstrated knowledge and application of fundamental engineering concepts.

  • Experience in product development process and design control within the medical device industry.

  • Proficient in use of flow cytometers, preferably BD instruments.

  • 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.

  • Strong interpersonal, written, and oral skills.

  • Experience working in Biosafety Level 2 Laboratories.

  • 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, manipulations, and interpretation.

Assets:

  • 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

  • Understanding and experience  of the principles of Design for Six Sigma

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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, or any other protected 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