Product Development Engineer

Company Name:
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, improved and line extensions for products. Activities include design, 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 product, 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)
5 or more years engineering experience in a regulated industry
Specific Licenses and/or Certifications:
Specialized Knowledge, Skill, and Abilities :
Proficient in Microsoft Word, Excel and Project and basic statistical analysis. 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.
Work Environment:
Physical Demands:
(if applicable)
Medical device, pharmaceutical or other GMP-regulated experience preferred.
Specific Licenses and/or Certifications:
Specialized Knowledge, Skill, and Abilities:
Knowledge of test design software and knowledge of CAD design software associated with solid modeling and drafting are a plus.

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