My Client, Axogen, Inc. is a global leader in innovative surgical solutions for peripheral nerve injuries located in Alachua, FL, which is near Gainsville. They are on the leading edge of nerve repair! Relocation assistance provided for the right candidate.
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 Manager 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.
This position could pay a competitive base salary plus 15% annual bonus plus stock options and a comprehensive benefits package.
If interested and more importantly qualified, send your updated resume with contact info to firstname.lastname@example.org and you will be contacted immediately.