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Axogen

Specializes in peripheral nerve repair devices

Senior Engineer - R&D, Biomaterials

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeTampa, FL, USAIn-person

About the Job

Requirements

  • A bachelor's degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Materials Science and Engineering, or a related field is required.
  • At least 5 years of experience in the medical device or pharmaceutical industry is required.
  • Product development experience is required.
  • Demonstrated ability to apply understanding of biomaterial composition, structure, and chemistry to solve product design challenges and drive desired performance in biological environments.
  • 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 preparing and delivering technical presentations.

Responsibilities

  • Apply expertise in biomaterials composition, structure, and chemistry to solve product design challenges and optimize product performance in biological environments.
  • Lead development of new products to treat peripheral nerve injuries from concept through commercialization, including medical devices, tissues, biologics, and combination products.
  • Serve as technical lead for product development projects of moderate complexity and contribute technical expertise to larger or more complex development programs.
  • Collaborate cross-functionally with Quality, Regulatory, Operations, Marketing, Medical Affairs, and other stakeholders to support product development and project execution.
  • Engage with external customers and internal stakeholders to understand user needs and translate them into product and design requirements.
  • Generate, prototype, and evaluate concepts and designs; optimize designs through testing, experimentation, analysis, and evaluation.
  • Execute product development activities in accordance with Design Control requirements, applicable quality system procedures, and relevant regulatory standards.
  • Plan and execute verification and validation activities to ensure products meet user needs, design requirements, and intended uses.
  • Participate in and may lead risk management activities, including hazard identification, risk analysis, implementation of risk controls, and evaluation of residual risk.
  • Design and conduct studies, analyze quantitative data, draw conclusions, and provide technical recommendations using sound technical expertise and engineering judgment.
  • Communicate technical information clearly and accessibly to internal and external audiences.
  • Ensure assigned activities comply with relevant regulatory and industry standards, including FDA and ISO standards.
  • Contribute to Axogen's intellectual property portfolio through invention disclosures, technical contributions, and related activities.
  • Maintain appropriate detailed documentation throughout all phases of Research and Development.
  • Investigate and evaluate new and existing technologies and remain current with developments in relevant technical areas.
  • Provide guidance, training, and mentorship to less-experienced team members.

Desired Qualifications

  • Experience in biomaterials development, including expertise in biomaterials composition, structure, and chemistry, is strongly preferred.
  • Experience with clinical surgical environments is preferred.
  • Experience working in an FDA-regulated industry with ISO and Quality System Regulation requirements is preferred.

About the Company

Axogen

Specializes in peripheral nerve repair devices

AxoGen develops and sells surgical solutions for peripheral nerve repair. Its core products include Avance Nerve Graft, a processed human nerve allograft that bridges nerve gaps without a second surgical site, and Axoguard devices for nerve coaptation, protection, and neuroma reduction. The products are distributed directly to hospitals and surgical centers, targeting plastic, hand, and oral/maxillofacial surgeons. The goal is to improve nerve repair outcomes and grow a sustainable business in the U.S. nerve repair market by offering clinically proven, FDA-cleared tissue grafts and devices.

Company size
501-1,000
Company stage
IPO
Headquarters
Alachua, FL
Founded
2002

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