Manufacturing Engineer I
Location: Branchburg New Jersey
Description: LifeCell Corporation is at the momment seeking for Manufacturing Engineer I right now, this job will be placed in New Jersey. Further informations about this job opportunity please read the description below. LifeCell Corporation develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures. LifeCell's leading technologies include:! Strattice™, for reconstructive and general surgical procedures; and AlloDerm®, for plastic reconstructive, general surgical, burn and periodontal procedures and Cymetra®, a particle form of AlloDerm suitable for injection.
LifeCell's patented tissue matrix was developed in 1994 as a graft for burn patients. Since then, AlloDerm's versatility has led to its use in many other reconstructive applications, allowing surgeons to restore tissue damaged through injury or disease - using the regenerative power of the patients' own tissues.
Position Summary: LifeCell is seeking a Manufacturing Engineer II to work in a dynamic, innovative, entrepreneurial spirited environment where together we change lives for the better. If you are self-motivated, enjoy a challenge and seek satisfaction knowing your efforts are making a difference in someone's life, then this opportunity is for you.
Position responsible for but not limited to, working under oper! ations/ manufacturing engineering department in developing and! implementing product, process, and equipment, and validation protocols, as applicable to ensure compliance to applicable regulatory requirements, internal company standards and industry practices. As a member of Manufacturing Engineering team, responsible for developing /supporting of revenue and process improvement projects and executing IQ/OQ/PQ protocols and making recommendations for changes and/or improvements. Ensure project completion per schedule, overall compliance and continuous quality and product/process improvement in an ever-changing, regulated environment.
Develop / write and execute validation protocols (IQ/OQ/PQ), and test scripts for equipment, systems, products and processes, including required annual re-qualifications and writing master validation plans and final validation reports.
Develop and perform engineering studies for improvements of equipment performance or process capabilities to reduce costs and cycles with ensuring validati! ons.
Assess effectiveness via auditing and validations of systems to ensure consistency of systems/practices across product lines and their conformance to regulations and other industry practices and identify area of continuous improvement.
Technical writing of Quality, Equipment and Processing Operating Procedures (SOP), Component Specifications and other documentation, as required.
Design and develop equipment and processes for use in the manufacturing of products. This may include in-house design or the use of products or components as purchased from vendors. Design, build and qualify fixtures, machines or equipment to facilitate manufacturing capability of products.
Draft and design layout of equipment, materials, personnel flow to illustrate maximum efficiency, using drafting tools and computer modelling. Assist in conversion of enterprise to lean methods including implementation of pull systems, 5s, and workflow analysis.
L! ead and effectively interface with manufacturing, production, quality, ! sales, marketing, external vendors, and other support teams to complete projects to meet production, quality, cost savings, and new product / process development goals within schedule and budget.
Revise manufacturing and engineering documentation, ensuring compliance between manufacturing process documentation, all applicable specifications, and engineering drawings while providing required operator training.
Experience in managing CAPA's corrective and preventative actions and collaborating with quality and manufacturing in the root cause verification and corrective action implementation
Qualifications
Position Requirements:
A minimum of a BS in Mechanical, Chemical, or Material, Physical / Technical Engineering (or other sciences)
A minimum of 3 years technical/engineering, validation and process development or operations experience with medical devices and equipments
Other Required Skills
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Preferred Qualifications
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knowledge of AutoCAD is a plus
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to LifeCell Corporation.
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This job starts available on: Sun, 17 Mar 2013 06:19:28 GMT