Job Description Summary

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. 

This position will provide oversight and support for quality staff whose primary responsibility is risk identification and consistency of approach identifying risk for new product development. As part of the Quality leadership team, this position plays a pivotal role in ensuring product and process quality, supporting business needs including new product development, production, and sustaining activities with an emphasis on combination products.

Job Responsibilities
•    Responsible for ensuring compliance with all Federal, State, local and company regulations, policies, and procedures related to medical devices and combination products.
•    Manage quality resources assigned to new product development programs, post market life cycle change projects (Sustaining) for combination products.
•    Support post market surveillance activities and complaint investigations.
•    Ensure appropriate QE representation on-project teams.
•    Provide QE resources required for test method development and validation, product verification and validation activities, coordination of reliability testing associated with new product development, evaluation of data for statistical validity, component qualifications, process capability studies, equipment qualifications, and process validations
•    Facilitate risk management process in compliance to appropriate external standards and corporate policies. Provide technical support to NPD teams in generating risk files for new products
•    Support failure investigations for product failures encountered during the new product development
•    Ensure QE support of field assurance investigations, as required
•    Maintain an up-to-date knowledge in the areas of quality assurance, regulatory compliance, design controls, risk management, statistical techniques and in the company products, policies, and procedures
•    Collaborate with the R&D organization to help facilitate the successful execution of the New Product Development Process and launching of robust products
•    Responsible and accountable for Quality Engineering (QE) deliverables required within the product development program and for ensuring that NPD projects are properly resourced with well trained and capable quality professionals
•    Recruit and develop quality engineering resources, as required
•    Coordinate quality activities with business units and manufacturing sites during the product development cycle, design transfer, and commercialization of new products
•    Other duties and projects, as assigned

Required Qualifications
•    BS Degree in Science or Engineering (or equivalent)
•    Minimum 12 years of experience with Class II or Class III medical devices including a minimum of 7 years of supervisory experience 

•    R&D experience
•    Ability to effectively deal and negotiate with members of multi-functional project teams and representatives of various government and regulatory agencies
•    Ability to travel within the USA and internationally
•    Working knowledge of ISO, MDD/MDR, GMP/QSR and other applicable regulations
•    Ability to travel up to 25%

Preferred Qualifications
•    Experience in combination products 
•    Design/Process Excellence or CQE certification

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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.  

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. 

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