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."
This position will lead and direct all activities in the manufacturing engineering department at Integra's Mansfield, MA manufacturing facility. This site manufactures medical devices primarily used in Neurosurgical applications. Working with Manufacturing, Purchasing, Quality Assurance, Finance and external suppliers, this position will lead a team of engineers and technicians to sustain and improve all plant manufacturing processes and associated equipment.
Supervises and leads Manufacturing Engineers and Technicians. Assigns projects, monitors results, and provides support and feedback.
Develops and executes Goals & Objectives and metrics for the Mfg Engr department.
Manages all equipment used in the Mansfield manufacturing processes, including equipment design & development, equipment selection, equipment upgrades, equipment troubleshooting & repairs, and supplier selections related to equipment and mfg facility.
Identifies manufacturing process improvements, analyzes solutions, and implements best options.
Identifies and implements all capital equipment requirements.
Leads and develops process qualification programs for all plant processes and equipment. Provides oversight to team to write and approve protocols and reports, analyze test results, and recommend actions.
Participates in ERP system data development and management supporting data verification and maintenance used in the production environment.
Supports all sustaining engineering activities for products manufactured in the plant.
Supports NPI product transfer activities into manufacturing with an emphasis on manufacturability and process scale-up.
Bachelor of Science degree in an Engineering discipline is required. Master of Science in Engineering and/or MBA is preferred.
Experience in an engineering and/or manufacturing environment is required - minimum 10 years with BS degree or 7 years with MS degree.
Experience in the medical device industry is preferred.
Knowledge of ISO13485 Design Control and its application in the manufacturing environment is preferred.
Knowledge of equipment process validation requirements, lean manufacturing techniques, and manufacturing equipment design and operation is required.
Familiarity with mechanical systems is required.
Six Sigma and Lean Mfg certifications are preferred.
Ability to develop and write Work Instructions and Standard Operating Procedures that are compliant to medical device industry standards is required.
Demonstrated leadership ability to lead a team of engineers is required. Must be able to give and receive constructive feedback; contribute to building a positive team environment.
Integra Lifesciences Holdings Corporation