AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient’s quality of life.
AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.
AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.
The Senior Engineer will lead important tasks and projects in new product development (NPD) including concept and prototype development, design, verification and validation, process development and transfer to manufacturing of tissue and biologic products and medical devices. This position will lead cross-functional teams to develop new products, processes and process improvements according to AxoGen Strategic Plan in compliance with all appropriate regulations and guidelines.
Responsibilities includes technology assessment; product/process development, validation and implementation; supply chain development and troubleshooting in support of manufacturing. He/she will also be responsible for activities in AxoGen’s R&D Lab including managing scientists and technicians and expanding laboratory capabilities.
This position is responsible for supporting, developing, and protecting company intellectual property, and assessing and remaining current with new developments and industry trends.
Educational Requirements / Qualifications
- Bachelor’s Degree in Engineering or related discipline (Graduate degree preferred)
- Solid experience in tissue engineering and regenerative medicine products (cleanroom processing, aseptic technique, tissue preservation, AATB standards)
- Minimum of three (3) years’ experience in leading cross functional teams in Product Development
- Demonstrated hands-on technical skill in planning and execution of product verification and validation and process validations and product/process transfer to manufacturing.
- Ability to work independently, lead in a collaborative team environment and influence leadership team and key stakeholders
- Strong interpersonal skills, mentorship skills, and time-management skills
- Working knowledge of requirements and regulatory approval process for Class II and Class III medical devices and biologics
- Experience in process troubleshooting and/or continuous improvement a plus
- Prior experience developing surgical instrumentation and/or electrical stimulation devices a plus
Primary Responsibilities: The specific duties of the Project Engineer/Engineering Manger include but are not limited to:
- Lead core teams of R&D engineers and scientists and extended team (QA, Regulatory Affairs, Marketing) to develop multiple NPD projects from development through product launch
- Manage all project activities to ensure on target, on time launch of new products according to AxoGen Strategic Plan
- Develop NPD project plans including Verification & Validation (V&V) plans, MS Project timelines, budgets and resource requirements.
- Direct cross-functional team in conducting hazard analysis (e.g., FTA, FMECA)
- Interface with Marketing/Sales, physician end users, and hospitals to understand customer requirements and critical product features. Gather, develop and document medical product specifications; identify competitive products/procedures; assist with product positioning decisions.
- Support and guide RA & QA with regulatory submissions.
- Manage projects via transparent, data-driven approach using metrics, dashboards and regular project (stage-gate) reviews
- Support the development and protection of company Intellectual Property through new invention disclosures, identification of potential licensing opportunities, and technical assistance with ongoing patent prosecution.
- Assess external technology and remain current with new development and industry trends, including ongoing investigation and evaluation of related research, products, and technology licensing opportunities. Research and obtain intelligence on competitors’ products and processes.
- Support the development of departmental strategic direction, business processes and project execution strategies.
- Contribute to recruiting and developing junior engineers and scientists, technicians, co-ops and interns.
We are seeking candidates who are AxoGenic, which means:
- Respect is the foundation for communication and action.
- Patient safety is our first priority.
- In being effective stewards of the gift of human tissue.
- In creating and maintaining a company culture that encourages and rewards honesty, openness, passionate debate – and fun!
- Individual ownership and empowerment lead to superior team results.
- The organization, its members and partners must consistently achieve agreed upon results with flexibility and mutual support.
- Speed is critical!