Integra LifeSciences Sr. Equipment Engineer in Plainsboro, New Jersey

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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

Responsibilities

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

  • 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

Qualifications

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:

  • BS/MS in Mechanical Engineering or equivalent 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

Location US-NJ-Plainsboro

Position Type Regular Full-Time

Category Engineering

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran stat