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 Process Development Engineer will lead important tasks and projects in R&D and Operations at AxoGen including concept and prototype development, design, verification and validation; process development and transfer to manufacturing of tissue and biologic products. This position will work concurrently with cross-functional teams to develop new products, processes and process improvements per the Company’s strategic roadmap in compliance with all appropriate regulations and guidelines.
The Process Development Engineer will focus on supporting development of new products and process optimization in AxoGen’s R&D Lab. Then, he/she will lead the transfer of developed products and implementation of process improvements to Operations and/or contract facilities. Responsibilities includes technology assessment; process development, validation and implementation; supply chain development; and troubleshooting/continuous improvement of manufacturing. 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)
- Three or more years of experience in regulated industry. (Medical or biotech experience preferred.)
- Experience with aseptic technique and processing in cleanrooms (Tissue experience preferred)
- Experience with process or equipment validations
- Experience in process troubleshooting and/or continuous improvement
- Experience contributing to NPD projects from concept through commercialization.
- Working knowledge of medical device requirements for Class I, II and III preferred
- Background in tissue engineering and regenerative medicine.
The specific duties of the Process Engineer include but are not limited to:
- Support development of tissue and biologics product and process optimization initiatives by developing new processes and process improvements in AxoGen R&D Lab
- Lead the transition of R&D processes to Operations and/or external contract facilities including:
- Develop process validation and implementation plan
- Coordinate schedule with Operations for pilot and validation runs
- Manage budget for process implementation
- Coordinate with Commercialization Team to schedule production of new products for pre-clinical and clinical evaluation, product launch and product ramp up.
- Support and guide Regulatory/Quality with Process Validation (e.g., IQ, OQ, PQ) protocols and reports and regulatory submissions
- Lead cross-functional team in conducting process hazard analysis (e.g., Process FMECA)
- Lead efforts for optimization of existing tissue/biologic processes including:
- Conduct capability studies and designed experiments to determine manufacturing process capability
- Collaborate/negotiate with external suppliers to develop custom processing equipment and advanced analysis/inspection methods
- Develop implementation plan for process improvements aligned with regulatory constraints and production schedule
- Provide day-to-day coordination of project activities; create and maintain project schedules, timelines, budgets, and resource requirements.
- 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.
- Maintain adequate records of formulae, process methods, and product procedures. Document and report assigned product and process development studies in a timely manner.
- 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.
- Maintain proficient knowledge of tissue and medical device safety standards and regulations, and provide input into product design and testing decisions.
- Perform other duties as assigned by Supervisor.
- Comply with all company policies, procedures, and SOPs
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!