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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.

For this position, experience in biomaterials development is strongly preferred. The ideal candidate will leverage expertise in biomaterials composition, structure, and chemistry to solve product design challenges, optimize material formulations, and drive desired performance in biological environments. This role requires designing and executing studies, analyzing data, drawing conclusions, and providing technical recommendations to support the successful development of new products and technologies. The position demands a proactive approach to problem solving, an understanding of medical device design controls and regulatory requirements, and the ability to manage multiple projects and priorities while maintaining a high level of attention to detail. The Senior Engineer is expected to independently lead product development projects of moderate complexity and contribute technical expertise to larger and more complex development programs.

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 stakeholders to understand user needs and translate those needs into product and design requirements.
• Generates, prototypes, and evaluates concepts and designs. Optimizes designs through testing, experimentation, analysis, and evaluation.
• Executes product development activities in accordance with Design Control requirements, applicable quality system procedures, and relevant regulatory standards.
• Plans and executes verification and validation activities to ensure products meet user needs, design requirements, and intended uses.
• Participates in and may lead risk management activities including hazard identification, risk analysis, implementation of risk controls, and evaluation of residual risk.
• Applies sound technical expertise and engineering judgment to design and conduct studies, analyze quantitative data, draw conclusions, and provide technical recommendations.
• Effectively communicates technical information in a clear and accessible manner to both internal and external audiences.
• Ensures assigned activities are performed in compliance with relevant regulatory and industry standards (e.g., FDA, ISO).
• Contributes to Axogen's intellectual property portfolio through invention disclosures, technical contributions, and related activities.
• Maintains appropriate detailed documentation throughout all phases of Research and Development.
• Investigates and evaluates new and existing technologies and remains current with developments in relevant technical areas.
• Provides guidance, training, and mentorship to less-experienced team members.

Location

111 West Oak Ave., Tampa, FL  33602

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