Sr. Engineer, R&D (Biomaterials)

axogen; Tampa (FL); On-site; USD 92,293 - 115,367; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k matching

Paid time off

Holidays

Tuition reimbursement

Parental leave

Stock purchase plan

Disability insurance

Job summary

Axogen is seeking a Senior Engineer, R&D to lead the development of innovative products addressing peripheral nerve injuries from concept through commercialization. You will collaborate with Quality, Regulatory, Operations, Marketing and Medical Affairs to ensure alignment and timely execution, using strong technical communication across audiences.

The role requires conducting studies, analyzing data, and providing technical recommendations, while managing multiple projects with attention to

Qualifications

• Strong technical communication skills for diverse audiences.
• Experience in medical device product development and design controls.
• Understanding of regulatory requirements (FDA/ISO) for medical devices.
• Ability to lead projects and collaborate with QA, Regulatory, Operations, and Marketing.

Responsibilities

• Lead development of new medical devices and technologies from concept to commercialization.
• Serve as technical lead for moderate complexity programs.
• Collaborate with QA, Regulatory, Operations, Marketing and Medical Affairs.
• Engage with customers and stakeholders to translate needs into design requirements.
• Generate, prototype, and evaluate designs; optimize through tests and analysis.
• Ensure activities comply with Design Control and quality systems; conduct V&V.

Skills

Technical communication

Cross-functional leadership

Regulatory awareness

Problem solving

Attention to detail

Education

Bachelor's degree in Biomedical/Mechanical/Chemical Engineering or Materials Science

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 or 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

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.