Sr. Engineer, R&D (Biomaterials

Sr. Engineer, R&D (Biomaterials)

Tampa, Florida, United States

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you'll love working at Axogen:

• Friendly, open, and fun team culture that values unique perspectives
• Company-wide dedication to profoundly impacting patients' lives
• Comprehensive, high-quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Engineer, R&D

The Sr. Engineer, Research & Development, is an experienced product development professional responsible for leading the development of innovative products to treat peripheral nerve injuries from concept through commercialization. This role collaborates closely with cross-functional teams including Quality Assurance, Regulatory Affairs, Operations, Marketing, and Medical Affairs to ensure alignment and effective project execution. The Senior Engineer must demonstrate strong technical communication skills and effectively adapt communication to a variety of internal and external audiences.

Requirements of the Sr. Engineer, R&D

• Bachelor's degree required in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science and Engineering, or a related field.
• Minimum of 5 years of experience in the medical device or pharmaceutical industry. Product development experience required.
• Demonstrated ability to apply an understanding of biomaterial composition, structure, and chemistry to solve product design challenges and drive desired performance in biological environments.
• Experience with clinical surgical environments preferred.
• Experience working in an FDA-regulated industry with ISO and Quality System Regulation requirements preferred.
• Demonstrated understanding of product development processes, design controls, risk management principles, and verification and validation methodologies within a regulated medical device environment.
• Demonstrated ability to communicate technical information clearly and effectively to diverse audiences, including the preparation and delivery of technical presentations.

Responsibilities of the Sr. Engineer, R&D

The specific duties of the Sr. Engineer, R&D include but are not limited to:

• Applies expertise in biomaterials composition, structure, and chemistry to solve product design challenges and optimize product performance in biological environments
• Leads the development of new products to treat peripheral nerve injuries from concept through commercialization, including medical devices, tissues, biologics, and combination products.
• Serves as the technical lead for product development projects of moderate complexity and contributes technical expertise to larger or more complex development programs.
• Collaborates cross-functionally with Quality, Regulatory, Operations, Marketing, Medical Affairs, and other key stakeholders to support successful product development and project execution.
• Engages with external customers and internal…