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 Operations Specialist primary responsibility will be to support Manufacturing Operations with technical aspects for projects including work in progress documentation and technical review in order to insure quality documentation. Additional responsibilities include reviewing processing records, evaluating test results, report writing, updating procedures and forms, building Bill of Materials and production documentation.
Educational Requirements / Qualifications
- High School diploma or equivalent required. Associates Degree in engineering, science or equivalent preferred
- At least one year of experience in a manufacturing environment
- Ability to understand processing and release requirements
- Excellent documentation skills
- Computer proficiency in Microsoft office including Word and Excel
- Excellent organizational skills
- Excellent problem solving Good communication skills
- Proven ability to work on multiple projects simultaneously in a fast paced environment with minimal supervision.
- Six Sigma certification
- Experience in medical device, tissue processing, or biologics
The specific duties of the Operations Specialist include but are not limited to:
- Assisting with engineering projects
- Reviewing processing records, test results, and other operations documentation for completeness and correctness
- Work with Quality Assurance to ensure compliance with all federal, state, and AATB regulations.
- Updating of forms and procedures
- Writing reports summarizing test results
- Assist with resolving non-conformance issues including risk analysis and investigations
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!