Principal Process Engineer (IRC2596)
Location: Plainsboro New Jersey
Description: Integra Life Sciences is in need of Principal Process Engineer (IRC2596) right now, this career will be placed in New Jersey. Detailed specification about this career opportunity please give attention to these descriptions. Principal Process Engineer
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can co! ncentrate 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, 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.'
Description:
Reporting! to the Sr. Manger, Equipment & Process Engineering Manager, t! his position is responsible to execute and manage project assignments in the evaluation, selection, and application of various engineering techniques, procedures, and criteria with minimal supervision. Independently plans, schedules, and leads detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Solves basic and complex problems identified through process characterization, monitoring and trending. Applies innovative approaches in the development of new processes, equipment, and systems. The incumbent should be able to complete complex design and engineering tasks and manage projects with little assistance. This includes constructing detailed, accurate project schedules, interfacing with internal and external engineering & technical resources in solving project problems, and having the ability to prioritize multiple projects and tasks.
To perform this job successfully, an individual must be able to perform eac! h essential duty satisfactorily.
Responsible for process engineering and project management to support improvement of existing processes, and introduction of new products and processes. These projects are typically higher level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly
Responsible for total Project management, process development, process improvement, IQ/OQ/PQ validations, and Manufacturing process troubleshooting. Must be able to manage the project in its entirety, and be able to perform / deliver specific project tasks as necessary
Responsible for analysis and upgrade of utility systems when needed (WFI, DIUF, HVAC, CCA, and steam generation). Lyophilizer experience is a definite plus
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture
Provide daily a! nalytical and technical support to meet manufacturing objectives
As! semble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs
Lead teams in performing and updating Process FMECA risk management
Effectively implement problem solving skills and techniques to identify potential issues, assess their impact and develop and implement mitigation and resolution plans and activities
Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, and Engineering) and supporting members (Corporate Regulatory, Finance, etc.). Includes such tasks as development of Manufacturing requirements, accounting documentation, specifications, validations, and
Engineering drawings and ECN paperwork
Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra’s procedures and! statutory requirements (US FDA and ISO)
Provide technical input for analysis of process changes
Develop P&ID and PFD as required
AutoCAD and/or SolidWorks experience preferred
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If you were eligible to this career, please email us your resume, with salary requirements and a resume to Integra Life Sciences.
If you interested on this career just click on the Apply button, you will be redirected to the official website
This career starts available on: Wed, 16 Oct 2013 07:52:53 GMT