Job DescriptionResponsibilities:
- 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: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.
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.
Primary Work LocationUSA UT - Salt Lake City BAS
Additional LocationsUSA NC - Durham - Davis Drive, USA NJ - Franklin Lakes
Work ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information 
