Integra LifeSciences

Process Technician

Vacancy ID
2017-24759
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, 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, tissue reconstruction 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."

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

  • Assist in efforts to create novel processes, leading to full scale manufacturing of Integra Regenerative products.
  • Perform hands-on laboratory work for prototyping, testing, DOE to optimize and scale-up processes from R&D to full-scale manufacturing.
  • Prepare samples for engineering studies including product prototypes, packaging, and shipping investigations.
  • Effectively implement problem solving skills and techniques to identify potential issues, assess their impact, and develop and implement mitigation and resolution plans and activities.
  • Generate technical documents/reports such as URS, FAT, and engineering study reports.
  • Assist with testing and calibrating laboratory equipment in preparation for designed studies.
  • Work with Process Engineering team and vendors/suppliers to develop new equipment and establish raw material specifications for new and/or improved processes.
  • Apply experience with manufacturing process equipment to assist in the selection and/or design of equipment from prototype and full scale manufacturing.
  • Work to gain expertise in Integra’s current technical proficiencies and manufacturing processes.
  • Ensure that all appropriate documentation and specifications are generated in compliance with Integra’s procedures and statutory requirements (FDA and ISO).

Provide technical input for analysis of process changes in the above areas.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education

    • BS in Mechanical Engineering, Pharmaceutical Engineering, Chemical Engineering, Materials Science, or equivalent.
  • Use of statistical process tools desired: Minitab, Six Sigma, Lean are a plus

 

Experience

  • 3+ years of experience in medical device or pharmaceutical environment.
  • Experience with Quality System Regulation (QSR), GMP, Design Control, and Process Validation guidelines applied to the Medical Device industry.
  • Knowledge of validation fundamentals (IQ/OQ/PQ).
  • Experience in clean rooms, lyophilization or biomaterials are desirable.
  • Practical product fabrication a plus.
  • Use of statistical process tools desirable, Minitab a plus.

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