BD (Becton, Dickinson and Company) Jobs

Job Description Summary

This position is reporting to the Associate Director Combination Product services of ZebraSci. As part of the BD/ZebraSci Combination Product Services team, the Sr. Engineer, Combination Products Technology Development, will assist with technical and scientific activities related to combination product technology, test method development and execution, and will serve as a technical contact for ZebraSci Clients, Marketing/Operation team.

This position performs advance technical analyses of drug delivery systems, designs and builds equipment's and fixtures, develops and validates test methods, and helps implement new testing technologies. S/he will assist in planning, performing and analyzing bench-level engineering tests or research experiments for drug-device combination products and medical devices. Position requires that candidate will develop and transfer various tests including but not limited to Design Characterization, Design Verification and Batch release testing to support operations.

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.

PRIMARY DUTIES, RESPONSIBILITIES & AUTHORITIES :

• Supports Technology Development team in the following:

• Author standard operating procedures, train and coach technicians and Engineers

• Develop Design verification plan and equipment validation strategies and execute right at first time within the defined budget and timelines

• Design and develop testing approaches, fixture design, and data analysis

• Authors test methods, test protocols, test method validations, and test reports

• Coordinates with Technology Development team to discuss and resolve challenges with service projects

• Lead technical initiatives related to combination products testing services, methodologies, and instrumentation

• Lead new equipment programs, tests, methods, instrumentation, and procedures.

• Plans and performs experiments that support new product or technology feasibility testing. Develops new methodologies or conducts routine procedures as needed.

• Interfaces with machine shop to execute fixturing development and fabrication to support experimental designs, and performs testing of product experimentally as required.

• Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing and troubleshooting)

• Keeps a working knowledge of commonly prescribed methods, background information, and troubleshooting strategies including cGMPs and relevant ISO and ASTM guidelines

• Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events

• Makes recommendations for edits, enhancements, and/or new procedures

• Assist with edits, review, issuance and archiving of quality system documents as needed

• Effectively communicates, orally and written, project progress and results within the Technology Development and operations team

• Skilled in effectively presenting and communicating performance results and test outcomes

• Communicates challenges, scheduling or testing conflicts and other issues to management in a timely manner

• Provides guidance to lab staff as needed

• Understands documentation requirements per cGMP

• Able to troubleshoot and provide technical assistance for Root Cause Investigations

• Assists staff, including activity training and oversight when needed

• Works and communicates openly and collaboratively with colleagues and staff

• Responsible to maintain the lab and storage areas in a clean an organized manner.

• Demonstrates superior planning and organization skills to balance a multitude of projects simultaneously

• Supports the Services Technology Development Management, as needed

• Support other activities and duties as needed or assigned

KNOWLEDGE AND SKILLS :

• Hands on experience in design and development of drug-device combination products and/or medical devices

• Experience in operation of mechanical measurement equipment (e.g. Instron, Zwick), vision systems (Keyence), and container closure integrity instrumentation

• Experience with technical document generation, execution, and reporting

• Has technical and practical knowledge of protocol and procedure development and test report generation

• Experience with test method development and validations (MSA, Gage R&R, etc.) is desirable

• Hands on experience in test fixture design and development

• Proficient in CAD (SolidWorkds) for fixture designing

• Knowledgeable of 3D Printers for rapid prototyping and fixture development

• Application of statistical and analytical methods such as Design of Experiments, ANOVA analysis, and statistical software (Minitab, JMP, etc.)

• Superior communication skills, both written and oral.

• Knowledge of GLP, cGMPs, 21CFR820.30, ISO and ASTM procedures beneficial.

• Knowledge and experience with common prescribed methods such as the ISO and ASTM procedures.

• Demonstrated attention to detail with the ability to organize and lead multi-faceted tests in a fast-paced environment and manage changing priorities with the capacity to effectively communicate across the organization.

EDUCATION AND EXPERIENCE :

Bachelor’s or Master’s degree in Mechanical/Biomedical/Chemical engineering discipline plus relevant experience related to combination product or medical device development and/or testing:

• 5+ years of experience with a MS

• 8+ years of experience with a BS

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 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 Temecula

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.