Product Development Engineer
Aziyo Biologics is a fully integrated, commercially oriented regenerative medicine company. Since its founding in 2015, the company has expanded through acquisitions and strategic partnerships, creating a high growth commercial entity. Its proprietary products are used in cardiovascular, orthopedic, and other medical specialties.
This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s goals and objectives as it relates to research and development.
This position is responsible for driving the product development of ECM based regenerative products and drug/device combination products while ensuring compliance with Aziyo’s quality and regulatory standards. The successful candidate will have the opportunities to lead technology and product development from the feasibility phase to product commercialization. The successful candidate may also lead the design, optimization and qualification of a broad range of bioassays, analytical methods, mechanical methods, in vitro and in vivo test methods (in house or through CROs) to support regulatory submissions and product launch.
Position reports to Director, Engineering
Essential Duties & Responsibilities:
- Lead or support the design and characterization of drug/device combination products in accordance with industry standards.
- Support prototype and pilot production of new products in coordination with Aziyo’s Manufacturing and Quality Control systems.
- Establish the testing plan, device limitations and acceptance criteria and ensure the timely completion of the technical deliverables
- Maintain state-of-the art knowledge in scientific principles, theories and clinical practice in one or more Aziyo’s strategic focus areas.
- Participate in development of patent applications.
- Maintain accurate and timely records of design and development activities in accordance with written procedures.
- Comply with Aziyo’s Quality systems.
- Lead project management teams.
- Collaborate with multiple functions, including Marketing, Regulatory Affairs, Quality and Clinical Operations.
- Present data to all levels of the Company, including senior management and peers.
- Minimum Bachelor’s degree in general science or engineering (Biomedical Engineering, Chemical Engineering, Material Science, Chemistry, Life Sciences, or related field) from an accredited college or university or an equivalent combination of education and work experience.
- Advanced degree preferred.
Experience and Skills:
- Minimum of 5 years’ experience within Medical device (especially combination device), Biotech or Biopharm.
- Preferred experience with drug-device combination product, controlled release, biomedical engineering, or related engineering.
- Preferred experience with test method and analytical method development and validation.
- Preferred experience with Design Controls and FDA submissions.
- Excellent written, communication, and presentation skills
- Proficient knowledge of computer programs (word processing, spreadsheets, and presentations)
- Must be able to stand for long periods of time.