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BD (Becton, Dickinson and Company) Manager, Clinical Systems Verification in San Jose, California

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.

The Manager, Clinical Systems Verification will lead an energetic and diverse team of engineers and scientists in the Design Assurance Engineering group. The team plays a critical role on product development teams, from technical development through launch, in ensuring that product designs meet the performance and quality needs of our customers. The Systems Verification Manager must be passionate about design quality and have demonstrated experience working collaboratively to influence complex designs throughout the design process. Experience successfully navigating multi-national regulations including CE-IVD and US FDA 510(K) submissions is preferred. The Manager achieves results through leading associates with diverse backgrounds who are committed to a culture of innovation, customer centricity, regulatory compliance, quality, continuous improvement and safety. He/she will be responsible for developing, leading, and growing a world class characterization and verification workforce as a competitive advantage for the business.

This position reports to the Director of Design Assurance Engineering in the R&D function.

Job Responsibilities:

  • Defines strategy for clinical Systems Verification and ensures alignment with our global partners.

  • Builds & maintains a high performing and engaged team.

  • Prioritizes team’s performance & career development.

  • Sets expectations for continuous learning and improvement across the department.

  • Identifies and builds team capabilities, tools, and processes to ensure world class verification methodologies are employed.

  • Manages and coordinates the resources responsible for the activities of the Systems verification and group that includes: planning, timeline development, protocols writing, protocol execution and report writing.

  • Identifies and builds team capabilities, tools, and processes to ensure world class verification methodologies are employed.

  • Establishes and delegates operational objectives and assignments that are in-line with business strategic objectives and departmental mission and vision.

  • Maintains substantial knowledge of product development principles and theories and best practices.

  • Communicates program status, progress, problems, and procedures to upper management.

  • Develops and monitors budgets for operational and capital expenditures and defines resource requirements.

Education and Experience:

  • Minimum of a Bachelor's degree in Engineering, Cell Biology, or related discipline.

  • Minimum of 5 years' related experience in a research/clinical/product development or industrial laboratory.

  • Demonstrated ability to plan, implement and document complex development efforts.

  • Ability to be effective in complex projects with ambiguity and/or rapid change

  • Ability to manage multiple projects at various stages of the product development process.

  • Must possess the ability to think strategically and exhibit effective analytical and problem-solving skills.

  • Effective interpersonal, leadership and negotiation skills, including effective oral and written communication skills.

  • Ability to set a vision and engage own team to reach that vision. Ability to champion and execute customer-centric approaches, ideas, methods, and processes.

  • Natural collaborator. Leads through building relationships; motivated by collective success.

Assets:

  • Minimum of 2 years of management/supervisor experience highly preferred.

  • Knowledge of immunology, hematology and immunochemistry.

  • Familiarity with medical device development, including cytometry relevant guidelines such as CLSI.

  • Current knowledge of routine and advanced flow cytometry applications used in the clinical and research markets including associated reagents, hardware and software.

  • Experience developing products in a Phase Gate Product Development process. Experience developing test strategies to meet product requirements.

  • Demonstrated experience successfully implementing new tools for verification, including automation and simulation, is a plus.

  • Previous experience with FDA 510(K) submissions is preferred.

  • Experience managing multiple labs with complex equipment and instrumentation, chemical and biohazards.

  • Experience contracting with, and managing, third party consultants within and outside the U.S a plus.

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 https://jobs.bd.com/

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

Primary Work Location

USA CA - San Jose

Additional Locations

Work Shift

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.

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

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