Senior Research And Development Engineer

3 weeks ago


Silver Spring, United States Elutia Full time
  • They ensure seamless product development and facilitate tech transfer for successful clinical and commercial use by applying critical thinking skills to solve technical issues.
  • Designing and characterizing biological matrices (decellularized ECM, collage, polymer) and drug/device combination products according to industry standards.
  • Developing drug coating and alternative drug delivery methods for sustained or extended release products.
  • Leading project development and overseeing tech transfer to manufacturing for clinical and commercial use.
  • Supporting a successful and efficient regulatory approval process, including 510(k) or PMA pathways, to ensure compliance with FDA requirements.
  • MS or PhD in life sciences, chemistry, material sciences, biomedical engineering or related field from an accredited college or university, or an equivalent combination of education and work experience.
  • Preferred experience in one of the following areas: biological material such as collagen and decellularized ECM; polymer science; controlled release and drug delivery
  • Proven experience with Design Controls and the regulatory approval process, including FDA submissions such as 510(k) and PMA pathways.


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