Staff Engineer, R&D
Job Description
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 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
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Company Information
Location: Alachua, FL
Type: Hybrid