Manager, Clinical Systems Verification

Company: BD (Becton, Dickinson and Company)
Location: San Jose
Posted on: June 25, 2022

Job Description:

Job Description Summary Job Description Be 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. We are recruiting for a highly-driven Staff Systems Engineer to work with a cross-functional team to develop and sustain Flow Cytometry technologies. The Staff Systems Engineer will drive technical aspects of projects focusing on complex cell analysis systems and solutions. The candidate will function within a group that acts as the hub of product development within the R&D organization defining the direction of performance requirements, interfaces, subsystem trade-offs and traceability of design control requirements. This role involves utilizing technical knowledge and engineering tools and methodologies to define and connect pieces across different functional elements (Software, Mechanical, Electrical, Fluidics, and Optics) within a regulated environment. You will ensure the product requirements are defined/maintained and the lower-level functional design teams deliver to those requirements. This role offers an exciting opportunity to make a far-reaching impact. Job Responsibilities: * Define and drive system-level requirements and architectural decisions. * Communicate with users, scientists, and customer-facing associates to improve the customer experience. * Develop system and subsystem requirements. * Play an essential role in Risk Analysis and FMEA files. * Develop and execute characterization, integration and test protocols. Use findings to drive decision-making and iterate on the design. * Utilize modeling tools to simulate and analyze systems, subsystems and data. * Communicate requirements and results with the cross-functional teams. * Provide technical expertise within the Systems Engineering team and cross-functional project teams to support development objectives. * Contribute to best-in-class systems engineering functional excellence, incorporating a data-driven approach with focus on superior user experience. * Participate in Design and Technical Reviews to ensure sound decision making is made across the program. * Provide support to sustaining engineering team for released and legacy instruments in production and at customer sites. * Review and analyze technical proposals or modifications for design feasibility and system capability. Minimum Qualifications: Education and Experience: * Minimum of a Bachelor's degree in an engineering discipline, e.g. Biomedical, Electrical, or Mechanical. Graduate degree is highly preferred. * 10+ years of hands-on experience in one or more areas related to flow cytometry or cell analysis such as signal processing, embedded systems, electronics, software, fluidics, optics, and/or assay reagents strongly preferred. * Experience in experimental techniques, statistical analysis & engineering investigation techniques. * Experience with medical devices required. * Experience working in a regulated environment is preferred. * Familiar working with external contract design and manufacturing facilities. * Familiarity with regulations and compliance testing is desired. * Familiarity with requirement management tools is desired. Knowledge and Skills: * Strong problem-solving and troubleshooting skills. * Must be a self-starter. * Strong technical leadership and interpersonal communication skills. * Excellent oral, written, and presentation skills. * Ability to work effectively in cross-functional teams. For many roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, weekly testing for COVID-19 may be available instead of vaccination. 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 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. PDN #LI-PRO Primary Work Location USA CA - San Jose Additional Locations Work Shift

Keywords: BD (Becton, Dickinson and Company), San Jose , Manager, Clinical Systems Verification, Healthcare , San Jose, California