Distinguished Engineer, Quality
BDAbout the role
We are the people who give possibilities purpose
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.
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.
As a Distinguished Engineer, Quality at Becton, Dickinson and Company, you will be a recognized technical leader, driving significant advancements in quality engineering methodologies, strategies, and practices across the organization to ensure the highest standards of product safety, efficacy, and compliance.
Key Responsibilities:
Provide expert guidance and strategic direction on complex quality engineering challenges throughout the product lifecycle, from concept to post-market surveillance.
Lead the development, implementation, and continuous improvement of advanced quality systems, processes, and methodologies (e.g., Six Sigma, Lean, Design for Quality, Statistical Process Control).
Represent the organization as a subject matter expert during regulatory audits and inspections (e.g., FDA, ISO, MDR), effectively communicating compliance strategies and resolutions.
Develop and implement advanced metrics and KPIs to monitor quality performance, identify trends, and drive continuous improvement initiatives.
Drive proactive identification and mitigation of quality risks, utilizing sophisticated analytical tools, reliability and statistical techniques
Evaluate external technologies, intellectual properties, and suppliers for business development opportunities to solve complex problems
Participate in engineering advisory board (e.g., ISO committee, validation board, industry forums)
Train, coach, and guide lower level employees on highly complex or novel procedures
May be selected as an Independent Reviewer for design review
Lead training, new system procedures, and new method development
Extensive experience with risk management tools and techniques (e.g., DFR, FMEA, PHA, FTA).
Proficiency in statistical software (e.g., Minitab, JMP) and advanced statistical analysis.
Ability to travel domestically and internationally as required.
Adherence to BD Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Other incidental duties
Education and Experience:
Bachelor's Degree in Engineering or Scientific field, 12 years experience including either industry or industry/education Required or
Master's Degree or equivalent in Engineering or Scientific field, 11 Year experience including either industry or industry/education Required or
Ph.D. or equivalent in Engineering or Scientific field, 8 years experience including either industry or industry/education Required
Additional Skills:
Quality SME with end-to-end product lifecycle experience from new product develop to post market.
Engineering expertise design, materials, and processes for complex electro-mechanical systems for hemodynamic monitoring capital equipment and sensors.
Demonstrated expertise and deep understanding of global medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, MDSAP).
Ability to translate highly complex and technical information to all levels of the organizations
Exceptional analytical, problem-solving, and critical thinking skills, demonstrating knowledge on using advanced tools such as (DMAIC, Fault-Tree Analysis, Shainin Red-X, Reliability Modeling and Predictions)
Proven track record of leading significant quality improvement initiatives and i
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