Integra LifeSciences Sr. Equipment Engineer in Plainsboro, New Jersey
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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
The Senior Equipment Engineer must be able to perform each of the following essential duties.
Responsible for technical project support for improvements/retrofits to existing equipment and new technology development activities. These projects are typically of increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.
Define equipment requirements and specifications based on process requirements, operational needs, Integra safety requirements, and internal customer needs. Work with outside equipment suppliers to design or redesign machines or components, acquire components, and assemble and test the machines. Assist in vendor selection and qualification, and machine procurement project management
Serve as technical resource to equipment development teams for conceptualizing, developing and implementing new manufacturing equipment and procedures that improve yields, efficiency, compliance, or safety.
Troubleshoot, repair and improve existing process equipment
Provide technical input and/or review protocols for equipment and process experimentation and validation
Perform timely technical investigations/experimentation and provide practical analysis and solutions
Write engineering studies and process protocols
Write maintenance, calibration, test and operational procedures
Write and defend complex technical reports and project summaries
Provide technical expertise to project teams and managers
Discover opportunities for equipment or process improvements and recommend solutions
Perform all duties in accordance with regulatory bodies and systems such as FDA, OSHA, EU/ISO, EPA.
Provide analytical and technical support to manufacturing operations
Communicate project status using reports and visual aids
The requirements listed below are representative of the knowledge, skill, and/or ability required.
BS/MS in Mechanical Engineering or equivalent experience.
Type and Number Years of Experience
Minimum of 10 years of equipment engineering experience, 5 years minimum in pharmaceutical or medical device industry
Experience with Quality System Regulation (QSR), design control, validation, engineering change control and ISO-13485
Experience with statistical process concepts and tools
Six Sigma experience (green or black belt a plus)
Fluency in solid modeling (SolidWorks), computational design and data analysis (using MS Excel and/or Minitab)
A strong interest in hands-on troubleshooting and experimentation.
Vacancy ID 2018-27369
Position Type Regular Full-Time