Integra LifeSciences

  • Manufacturing Engineer

    Vacancy ID
    2018-27138
    Location
    US-NJ-Plainsboro
    Position Type
    Regular Full-Time
    Category
    Engineering
  • Overview

    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 4,400 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

     

    It's a great time to join our growing company and become one of our impassioned colleagues making lives better for the patients we serve!

    Responsibilities

     

    Reporting to the Supervisor of Manufacturing Engineering, this position is responsible for support of manufacturing operations and process scale–up, process and equipment improvement activities. Oversee projects to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, implement statistical process controls, analyze and trend existing proce

    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.

     

    • Responsible for process engineering and project management to support process scale-up and current manufacturing operations. These projects are typically of increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly.
    • Responsible for projects aimed to evaluate, analyze, and improve existing processes, support the development of new manufacturing processes, and manufacturing process troubleshooting. Must be able to perform/deliver specific project tasks as necessary.
    • Oversee projects to implement statistical process control (as necessary), analyze and trend existing process parameters, process inputs and outputs, improve manufacturing yields, reduce manufacturing scrap, and error proof manufacturing processes.
    • Initiate, develop and implement IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations.
    • Coordinate specific efforts as required by the project team.  Includes such tasks as development of manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO) and Engineering Drawings.
    • Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs.
    • Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance Investigations, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective and Preventive Action(s) (CAPA support).
    • Provide daily analytical and technical support to meet manufacturing objectives.
    • Responsible for providing plant input in manufacturing process development, to include but not limited to, process design requirements, risk analysis, traceability matrix, design history file, etc.
    • Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full scale manufacturing. Evaluate and upgrade process equipment as required.
    • Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities.
    • Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with Integra’s procedures and statutory requirements (US FDA and ISO).
    • Provide technical input for analysis of process and equipment changes.

     

    Qualifications

    • BS (MS preferred) in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, or equivalent.
    • Minimum of 1-5 years’ experience in the medical device or pharmaceutical industry with experience in process development and/or process engineering.
    • Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines are required. Experience with biomaterials, in cleanrooms, and Lyophilization a plus.
    • Experience with Statistical Process Control tools required (SPC, Minitab, other software).
    • General chemistry, processing and material expertise.Considerable knowledge of the principles and practices of engineering as applied to various types of projects.
    • Ability to prepare complex technical reports, project summaries, and correspondence.
    • Exceptional practical problem solving skills, excellent organizational and communication skills.
    • Six Sigma. LEAN a plus.

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