Staff Scientist I

Responsibilities

• Participating in New Product Development projects team/Innovation and sustaining projects meetings as an SME, providing biocompatibility and other CPDT related inputs.
• Review and processing of change control submissions/change documentation.
• Serve as Sponsor Representative for biocompatibility and chemistry studies and contribute to design, execution, and interpretation of preclinical, biocompatibility, chemistry and toxicological evaluation programs for medical devices within BD.
• Author, Review and/or approve Biological Evaluation Plans and Biological Evaluation Reports to support regulatory filings such as 510(k), EU MDR and global submissions for BD products.
• Participation in AAMI ISO 10993 Standards Committees and other Industry consortia to represent CPDT Tox and provide inputs on behalf of BD.
• Scope of Accountability:
• Sole Contributor
• Position Requirements:
• Bachelor's degree in toxicology or a closely related field required, and 4 to 6 years of pre-clinical medical device development experience OR Master's degree in toxicology or a closely related field and 2 to 3 years pre-clinical medical device development experience.
• A broad background in biology/biocompatibility, toxicology and analytical chemistry including familiarity with recent methodologies and evaluation techniques (i.e., ISO 10993 and related guidances).
• Experience in an FDA-regulated medical device setting preferred.
• Ability to communicate and work effectively with national and international, internal and external teams.
• Must be able to multitask and operate effectively within a diverse work environment.
• Must be team oriented and have strong interpersonal skills and customer focus while functioning independently as an SME at the Salt Lake City, Raleigh, or Franklin Lakes location.
• Must have excellent scientific written and verbal communication skills.
• 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 learn more about BD visit https://bd.com/careers

Benefits

Additional Information

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.

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