Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryAs directed by the Quality Associate Director, the Senior Quality Engineer is accountable for supporting new product development, manufacturing, quality operations, and product maintenance for the Advanced Diabetes Care Platform through the application of Quality engineering skills for medical devices. This associate will handle projects and tasks, from product inception for pilot manufacturing, and product launch. The candidate will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.
The Senior Quality Engineer will work as a member of cross-functional project teams engaged in new product development and manufacturing for electrical, mechanical, and software driven medical devices. The individual will serve as a quality representative on project teams.
Support new product development projects following Design Control processes, responsibilities include supporting: quality planning, engineering and clinical product builds, design verification & validation, design reviews, risk management, design transfer, and manufacturing control planning aspects of the project.
Support manufacturing processes, including computer-controlled high speed processes.
Support change management process by analyzing change impact to product or process, identifying supporting tasks, and ensuring completion of deliverables.
Perform inspection and test method development and validation.Develop quality plans for receiving, in-process and final inspection.
Perform facility and process validation activities, including IQ, OQ, PQ, Software, capability analysis and DOE for automated manufacturing equipment.
Understanding and applying the Six Sigma methodology including Define, Measure, Analyze, Improve and Control and participate on improvement projects.
Support CAPA, non-conforming material handling, supplier management, complaint handling and procedure development.
Prepare technical documentation including plans, procedures and reports.
Support calibration and preventative maintenance activities, including review and approval of calibration certificates.
Support quality / regulatory audits and FDA inspections.
Knowledge of 21CFR 820, ISO 13485, ISO 14971, EU MDR 2017/745, design controls, and applicable medical device regulations.
Class II medical device experience
Excellent communication, problem solving, organizational and interpersonal skills are essential.
Ability to work in teams to obtain results is required.
Effective skills in analytical thinking and problem solving is required.
Self-motivated and directed, requiring minimal supervision.
Experience leading others through process mapping exercises and problem solving.
Professional certifications (CQE, CQA, CRE, etc.) are preferred.
Knowledge of statistical methodologies and software tools are preferred.
Six sigma training and certification is desired.
Project management skills are desirable.
Bachelor's Degree in Engineering is required.
Minimum of 5 years of industry experience.
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.
Primary Work LocationUSA MA - Andover
Work ShiftNA (United States of America)
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Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.