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, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and 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. Integra's Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. 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 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol \"IART.\"
Provides technical and engineering support to the Operations department. Coordinates Engineering Tech staff and activities in production areas. Designs equipment and floor layouts. Responsibilities include: project management, equipment and process improvement projects, supporting the introduction of new processes or equipment into the manufacturing facility, facility equipment, maintenance, calibration, and troubleshooting of equipment, leading investigational activities around non-conformances, operator training and operating procedure/batch record development, creating and developing CAD drawings. Acts as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts. Support shop floor activities and work with operators as required to complete daily operational targets.
Maintain and Support new and existing Operations Equipment
* Understand and be knowledgeable of all Equipment and Process Operations completed in the facility. This includes, site SOPs, Equipment documentation, capacity, setup, operation, disassembly, maintenance, cleaning, troubleshooting, monitoring, and programming of manufacturing equipment and facility. * Troubleshoot and organize the repair production equipment. * Effectively start, stop and operate all equipment and act as equipment SME.
Support Equipment related Quality Investigations and Initiatives.
* Lead and document investigational activities around events/non-conformances or customer complaints with effective root cause identification * Lead, present and implement Corrective &Preventative Action plans around manufacturing activities * Partner with Quality Assurance and other support groups to resolve process related deficiencies and material/product disposition. * Create or revise controlled documentation as required. * Lead training initiatives for new and existing operators participating in manufacturing operations
Ownership and Responsible for all Equipment and Facility Calibration and PM
* Direct staff and vendors to perform calibrations and/or verifications of instruments and equipment to approved job plans, work instructions and/or procedures. * Perform testing on electronic components to determine functionality level and capacity. * Utilize expertise of instrument, equipment, and loop calibrations of various parameters used within the sites's manufacturing operations, laboratories and facilities. * Perform in-house calibration and maintenance of production equipment * Complete all cGMP documentation associated with calibration and maintenance tasks. * Review calibration SOPs for accuracy during routine calibration or when a new instrument is introduced into the calibration database. Create or revise the SOPs as needed. * Create, update and maintain equipment service records
Perform Development and Design work
* Assist in the transfer of processes and/or equipment into development or production * Work with PD and Management staff on process development and validation activities * Work with Facility and Management staff to design appropriate floor layouts and drawings.
Process Improvement and Validation
* Organize and write validation protocols associated with the manufacturing process * Lead and support troubleshooting activities to minimize process downtime or re-occurrence * Identify key process indicators and collect data to drive manufacturing and yield improvements
* Bachelor's Degree in engineering or equivalent professional experience * 5-10 years of experience in the Medical Device industry or Pharmaceutical industry within a clean room environment * Excellent verbal and written communication skills * Strong technical writing abilities * Demonstrated organizational and communication skills. * Must possess strong leadership skills with team-focused attitude and approach. * Excellent troubleshooting and problem solving skills * Time management oriented with the ability to support overtime activities to meet project objectives * Demonstrated computer knowledge of Microsoft Office and Microsoft Project * Must read, write and speak in English, and communicate clearly and concisely * Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other National and International regulations and standards. * Understanding of Lean/six Sigma a plus. * CAD experience (AutoCAD) a plus
TOOLS AND EQUIPMENT USED
* Lyophilizers, homogenizers, saws, presses, grinder, vacuum pump, pH meters, thermometers, balances (scales), water bath circulators, humidity cabinet, centrifuge, blenders, air gun, slicer, flesher, drop indicator, PLCs, scalpels and temperature recorders, * Calibration and PM Software
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly
sit, listen, and speak. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
* Daily interaction with hazardous materials used in a controlled environment.