My client is a leading medical technology company that is growing. They will consider out of state candidates. This position is located in the Gainesville, FL area.
The R&D Manager will lead important tasks and projects in new product development (NPD) and sustaining engineering 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 supervise project leaders and also lead cross-functional teams to develop new products, processes and process improvements according to our Strategic Plan in compliance with all appropriate regulations and guidelines. He/she will also be responsible for managing activities in our R&D Lab including supervising scientists and technicians and expanding laboratory capabilities.
Responsibilities include technology assessment; product/process development, validation and implementation; supply chain development and troubleshooting in support 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)
- Solid experience in tissue engineering and regenerative medicine products (cleanroom processing, aseptic technique, tissue preservation, AATB standards)
- Minimum of five (5) years’ experience in leading cross functional teams in Product Development
- Experience managing engineers and scientists as direct reports
- 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, biologics and tissue (HCT/P 361) products
- 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:
- Manage multiple project teams of R&D engineers and scientists and extended team (QA, Regulatory Affairs, Marketing) to develop multiple NPD projects from development through product launch
- Supervise senior engineers, scientists and project leaders in 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 and technical design 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.
If interested and more importantly qualified, please send updated resume with contact info to email@example.com and you will be contacted immediately.
This position can pay a very competitive base salary plus bonus and excellent comprehensive benefits package.
Unfortunately, Visa sponsorship or transfer not available for this role.