Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.
Integra's orthopedic products include devices and implants for spine, foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair, and wound repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol 'IART.'
Responsible for the management of the Process and Equipment Engineering Group for 109 Manufacturing Operations. The group is responsible for the transfer and development of process and equipment specification, characterization, and implementation for the start-up of the 109 manufacturing facility. This position is responsible for characterization and implementation of new and existing processes to ensure robustness using a six sigma methodology. Manage new equipment development using external suppliers. Responsible for creating external equipment supplier relationships and managing them. Responsible for leading implementation of processes and equipment to support the transfer and start-up of production at the 109 production facility.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Actively participate with Plant Management in planning and implementing long and short term strategic goals for the 109 Manufacturing Facility and ensure these goals are communicated and executed against.
- Plan and administers efficient resource utilization (material and personnel) to achieve department and plant CIP and compliance goals.
- Responsible for engineering and project management to support existing product transfers from the existing 105 facility to the new 109 Facility ensuring that well characterized and robust processes are put in place.
- Collaborate with 105 plant Engineering, Quality, and Manufacturing stakeholders to ensure issues are not transferred to the new manufacturing facility and where appropriate characterization of processes/equipment are completed. Ensure lessons learned are communicated and improvements are shared between the plants.
- Drive the implementation of six sigma methodologies in the characterization of process to ensure robust and well identified CTQ’s.
- Responsible for project management, process development, process improvement, IQ/OQ//PQ validations, developing and meeting transfer goals and metrics, optimization of the transfer process to ensure that new equipment and processes are delivered in an efficient, timely, and compliant manner with robust manufacturing processes.
- Provide daily analytical and technical support to meet manufacturing objectives once products are transferred.
- Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture.
- Lead, support, and participate on special operations improvement projects as needed.
- Promote and Lead the implementation and use of six sigma and lean methodologies within the Process and Equipment Engineering Group.
- Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing working with outside suppliers
- Lead teams in performing and updating Process FMECA risk management
- Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities
- Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, Manufacturing Engineering, Calibration and Maintenance) and supporting members (Corporate Regulatory, Finance, etc.). Includes such tasks as development of Manufacturing requirements, accounting documentation, specifications, validations, Engineering drawings and ECN paperwork.
- Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra’s procedures and statutory requirements ( US FDA and ISO)
- Responsible for process scale up to plant standards and manufacturing volumes.
- Review, approve, and lead the executions of validations, work orders, drawings, and procedures.
- Provide technical input for analysis of processes changes, NC’s, and CAPA’s