R&D Engineer
Location: Edison New Jersey
Description: Musculoskeletal Transplant Foundation is hiring R&D Engineer right now, this job will be placed in New Jersey. More complete informations about this job opportunity kindly read the description below. The Musculoskeletal Transplant Foundation, the nations largest tissue bank, changes lives by connecting donors with surgeons and transplant recipients. As a non-profit service organization, MTF is dedicated t! o providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. Since our inception in 1987, MTF has recovered more than 60,000 donors and has distributed more than 3 million grafts for transplantation.
The Research and Development organization within MTF strives to maximize the donor gift by designing and developing new ways of using and processing musculoskeletal tissue as grafts or combined with other materials to create novel medical devices. Research scientists and engineers work together with surgeons to determine the needs of the recipient, and provide them with safety and efficacy data to support the appropriate use of the grafts.
Develop new products, processes and packaging within the MTF Design Control System. Drive the scale-up of process, product and packaging development activities for transition from R&D to Manufacturing.
Responsible for development of new, imp! roved and line extensions for products. Activities include des! ign, material selection, prototyping, testing, process development, equipment validation, process qualification and validation, and packaging/stability studies. Responsible for combining, analyzing and synthesizing data from multiple experiments and sources to make engineering recommendations.
Maintain a current knowledge of the state of the art for allograft tissue and medical device science. Track progress of competitive technology and applies this knowledge to development of new MTF tissue forms.
Develop mechanical, physical, chemical or biologic analytical test methods and test protocols; manage engineers and technicians in performing tests and recording information; generate, analyze and review reports required to meet Design Control requirements.
Responsible for engineering-scale process design, process development, process flow mapping and process equipment development as part of new product development, and product or process improvement.
Transfer pr! oduct, process and packaging development to the manufacturing and quality organizations as part of scale-up activities including training, documentation, and validations.
Plan Design of Experiment (DOE) activities and manage engineers and technicians in conducting experiments to establish product or process specifications.
Contribute to technical documentation in support of US and international regulatory requirements.
Manage technical personnel as direct reports or as part of a matrix management structure.
Assist on special projects and performs additional duties as assigned.
Bachelors degree in engineering discipline (e.g. Mechanical, Biomedical, Chemical, Materials Science) with 5 or more years engineering experience in a regulated industry. Medical device, pharmaceutical or other GMP-regulated experience preferred.
Proficient in Microsoft Word, Excel and Project and basic statistical analysis. Knowledge of test design software and knowledge ! of CAD design software associated with solid modeling and drafting are ! a plus.
Strong written and verbal communication skills. Ability to work within a multifunctional team environment.
Demonstrated success in development of new technologies from concept to market. Experience in project management and direct management of technical personnel desirable.
Addtional Preferences :
Experience working with outside designers and suppliers on new projects from concept thru early production.
Knowledge of Sterile processing/Sterile-fill a plus.
Working knowledge of all phases of design control with emphasis on design requirements, verification and risk assessment.
Experience with CNC and machining processes 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 Musculoskeletal Transplant Foundation.
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This job starts available on: Fri, 01 Nov 2013 09:30:45 GMT