Staff Engineer, R&D

Job Summary of the Staff Engineer, R&D

The Staff Engineer, Research & Development, is an experienced product development professional that will spearhead the creation of innovative products to treat peripheral nerve injuries, guiding them from initial concept through to market launch. This role requires close collaboration with cross-functional teams including Quality Assurance, Regulatory Affairs, Operations, Marketing, and Medical Affairs to ensure alignment and effective project execution.  The Staff Engineer must demonstrate exceptional technical communication skills and adapt their communication methods as appropriate for both internal and external audiences. This role requires designing and executing studies, analyzing data, forming conclusions, and providing strategic recommendations to drive the company mission. This position demands a proactive approach to problem-solving, an understanding of regulatory requirements, and the ability to manage multiple projects simultaneously while maintaining a high level of attention to detail.

Requirements of the Staff Engineer, R&D

• Bachelor's degree required in biomedical engineering, Mechanical Engineering, Chemical Engineering, Materials Science and Engineering or a related field.
• At least 7 years of experience in the medical device or pharmaceutical industry, including product development experience.
• Experience with clinical surgical environment preferred.
• Experience working in an FDA-regulated industry with ISO and Quality System Regulation requirements preferred.
• Expertise in communicating complex technical information clearly and effectively to diverse audiences, including the preparation and delivery of technical presentations.

Responsibilities of the Staff Engineer, R&D

• Leads the development of new products to treat peripheral nerve injuries from concept to commercialization, including medical devices, tissues, biologics, and combination products.
• Collaborates cross functionally with Quality, Regulatory, Operations, Marketing, Medical Affairs, and other key stakeholders.
• Engages with external customers and internal stakeholders to understand and prioritize their needs and translate those needs into design requirements.
• Ideates and prototypes concepts and designs. Optimizes designs through testing, experimentation, analyses, and evaluations.
• Defines and performs verification and validation activities to ensure products meet user needs, design requirements, and intended uses.
• Applies sound technical expertise and judgment to design and conduct studies, analyze quantitative data, form conclusions, and provide technical recommendations.
• Effectively communicates technical information in a clear and accessible manner to both internal and external audiences.
• Ensures all activities are performed in compliance with relevant regulatory and industry standards (e.g. FDA, ISO).
• Contributes to Axogen’s intellectual property portfolio.
• Maintains appropriate detailed documentation through all phases of Research and Development.
• Investigates and evaluates new and existing technologies and remains current with the state of the art in their technical expertise area(s).
• Mentors and trains other team members and may directly supervise one or more engineers.

Location

111 West Oak Ave., Tampa, FL  33602

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Benefits/Compensation