NPI Specialist II

Job Description Summary

With supervision, participates in new product introduction teams responsible for Documentation Control during the transfer of production processes to Operations. Assists in Continuous Improvement for process efficiency and product quality. Support Customer Complain investigation and may provide guidance to other lower-level associates.

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

DUTIES AND RESPONSIBILITIES

• Participate in new product transfer or sustaining or continuous improvement projects.
• May participate as a member of the operation team and support core team member Own the documentation tasks in the successful transfer of products and processes into manufacturing following the Global Product Development System
• Own documents for Reagents, Labeling, Quality, BOM changes, and routing updates during NPI from R&D to Ops.
• Monitor ACR, ECR/O, and other ECM documents to facilitate and coordinate the approval and implementation.
• Experience with BOM for reagents required.
• Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
• Supports validation activities through coordinating documentation.
• Supports Continuous Improvement projects by submitting documents in Quality System.
• Supports senior BPEs to analyze and solve problems in Production and Quality Control.
• Provides support in experimental strategy, problem characterization, data acquisition and analysis.
• Support root cause analysis for product complaints through submitting documentation of investigation, CAPA, pFMEA, and complaints forms.
• Supports in the designing, writing and executing of protocols, reports, data analysis and other quality documents.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements and raises concerns/issues to the management.
• Promotes a safe work environment.

MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor's degree in biological sciences with 5 years of relevant experience or Master's degree with minimum of 3 years of relevant experience.
• A minimum of 3 year experience in a FDA or ISO regulated production environment.
• Proven experience of working in cross-functional development teams
• Experience with SAP ECM required.
• Reagent product Document Control experience required.

Assets

• Proven product integration, process development and design transfer experience.
• Experience with Single Cell genomics and knowledge of Flow Cytometry is desired
• Excellent organization and time management skills.
• Effective written and verbal communication.
• Meticulous attention to details.

For certain 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, testing for COVID-19 may be available and/or required. 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 encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve 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. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

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 Diego (BDB)

Additional Locations

Work Shift