Development Engineer.
Position Overview.
The Development Engineer at Elutia is responsible for designing and developing biological-based medical devices, specializing in drug/device combination products according to industry standards. This role encompasses overseeing the entire development process, from initial concept through to commercialization. The Development Engineer leads prototype and pilot production, develops and executes test methods, and collaborates with cross-functional teams to advance Elutia’s product pipeline. They ensure seamless project development and facilitate tech transfer for successful clinical and commercial use by applying critical thinking skills to solve technical issues. Additionally, the Development Engineer contributes to the intellectual property portfolio and ensures compliance with regulatory requirements to gain product approvals and support product lifecycle management.
The successful candidate will work onsite at the Company’s Silver Spring, MD office.
Essential Duties & Responsibilities
- Designing and characterizing biological matrices and drug/device combination products according to industry standards. • Developing and executing test methods to support exploratory research and introduce new techniques.
- Supporting prototype and pilot production of new products in collaboration with Manufacturing and Quality Control Systems.
- Applying critical thinking skills to product development and design, troubleshooting technical issues in the lab.
- Establishing testing plans and ensuring timely completion of technical deliverables.
- Leading project development and overseeing tech transfer to manufacturing for clinical and commercial use.
- Utilizing quantitative data analysis skills to inform decision-making processes and effectively communicate results.
- Contributing to the intellectual property portfolio through innovative solutions.
- Supporting a successful and efficient regulatory approval process, including 510(k) or PMA pathways, to ensure compliance with FDA requirements.
- Maintaining accurate and timely records of development activities as per written procedures.
- Collaborating across multiple functions, including Marketing, Regulatory Affairs, Quality, and Clinical Operations.
Education & Experience
- MS or PhD in life sciences or engineering from an accredited college or university, or an equivalent combination of education and work experience. Relevant experience may be considered in lieu of advanced degree.
- 3-5 years’ experience within Medical Device or Biotech industries.
- Proven experience with Design Controls and the regulatory approval process, including FDA submissions such as 510(k) and PMA pathways.
- Preferred experience in the development of drug-device combination products.
- Demonstrated experience exemplifying our CRU values: contagiously confident, ridiculously relentless, unanimously united
- Demonstrated success in a fast-paced, entrepreneurial environment.
- Exceptional written, communication, and presentation skills.