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 proce…
Skills: Product Development, Design Controls, Risk Management, Verification and Validation, Technical Communication
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 proce…
Skills: Power BI, DAX, Dimensional Modeling, SQL, Microsoft Fabric
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 proce…
Skills: Scientific Literature Review, Technical Publication Analysis, Research Methodology, Preclinical Study Design, Clinical Study Design
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 proce…
Skills: Manufacturing Engineering, Automation, Process Improvement, CAD, SolidWorks
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 proce…
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 proce…
Skills: Market Development Strategy, Product Management, Strategic Planning, Market Segmentation, KOL Management
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 proce…
Skills: Quality Control Inspection, Batch Record Review, CAPA Management, Root Cause Analysis, Good Documentation Practices
Regional Sales Director, Breast Specialty - Southeast (IN, S. OH, NC, SC, TN, AL, FL, GA, and S. VA)
Nashville, Tennessee, United States · On-site
Senior$256M raised
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 proce…
Regional Sales Director, Breast Specialty - Southeast (IN, S. OH, NC, SC, TN, AL, FL, GA, and S. VA)
Charlotte, North Carolina, United States · On-site
Senior$256M raised
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 proce…
Regional Sales Director, Breast Specialty - Southeast (IN, S. OH, NC, SC, TN, AL, FL, GA, and S. VA)
Tampa, Florida, United States · On-site
Senior$256M raised
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 proce…
Regional Sales Director, Breast Specialty - Southeast (IN, S. OH, NC, SC, TN, AL, FL, GA, and S. VA)
Atlanta, Georgia, United States · On-site
Senior$256M raised
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 proce…
Regional Sales Director - Midwest (Minnesota/Wisconsin/Illinois)
Chicago, Illinois, United States · On-site
Senior$256M raised
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 proce…
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 proce…
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 proce…
Director, Market Development (Head & Neck Specialty)
Tampa, Florida, United States · On-site
$168k–$211k/yr
Senior+$256M raised
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 proce…
Skills: Market Development Strategy, Product Management, Strategic Planning, Clinical Acumen, People Leadership
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 proce…
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 proce…
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 proce…
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 proce…
Skills: Microsoft Dynamics 365 Finance & Operations, X++ Development, Power Platform, Azure Integration, SQL
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 proce…
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$92k–$115k/yr
Full-time
bachelor degree
Health Insurance, Dental Insurance, Vision Insurance, Matching 401k, Paid Time Off, Paid Holidays
Posted 2d ago
~40 hrs/week
Responsibilities
Lead the development of innovative products for peripheral nerve injuries from concept through commercialization. Collaborate with cross-functional teams to execute design controls, risk management, and verification and validation activities.
Requirements
Requires a Bachelor's degree in Biomedical, Mechanical, Chemical, or Materials Engineering with at least 5 years of experience in the medical device or pharmaceutical industry. Must have demonstrated expertise in product development processes and FDA-regulated environments.
Full 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 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.
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.
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:
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
#LI-AC1
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.
Salary Range
$92,293—$115,367 USD
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.
To restore health & improve quality of life by making restoration of peripheral nerve function expected standard of care
Industry
Biotechnology Research
Company size
201-500 employees
Founded
2002
Headquarters
Alachua, Fl
LinkedIn followers
24,563
Total funding
$256M
Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair.
Our mission is restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.
Offices: 13631 Progress Blvd, Suite 400, Alachua, Fl 32615, US · 111 West Oak Avenue, Tampa, Florida 33602, US · 300 Boone Rd, Suite a3, Burleson, Texas 76028, US · 349 S Main St, 4th Floor, Dayton, OH 45402, US · 913 Industrial Park Dr, Vandalia, OH 45377, US
Medical DevicePeripheral Nerve RepairBiotechnologyTissue EngineeringRegenerative MedicineTranslational ScienceProcessed Nerve AllograftBiologicsLife Scienceand Breast Reconstruction Nerve Repair
To restore health & improve quality of life by making restoration of peripheral nerve function expected standard of care
Industry
Biotechnology Research
Company size
201-500 employees
Founded
2002
Headquarters
Alachua, Fl
LinkedIn followers
24,563
Total funding
$256M
Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair.
Our mission is restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.
Offices: 13631 Progress Blvd, Suite 400, Alachua, Fl 32615, US · 111 West Oak Avenue, Tampa, Florida 33602, US · 300 Boone Rd, Suite a3, Burleson, Texas 76028, US · 349 S Main St, 4th Floor, Dayton, OH 45402, US · 913 Industrial Park Dr, Vandalia, OH 45377, US
Medical DevicePeripheral Nerve RepairBiotechnologyTissue EngineeringRegenerative MedicineTranslational ScienceProcessed Nerve AllograftBiologicsLife Scienceand Breast Reconstruction Nerve Repair