Must have experience or advanced training and demonstrate proficiency (e.g. Investigations, problem solving, total quality management, statistical methods, DHF remediation, Risk file remediation, problem analysis and resolution, materials science, design of experiments etc.)
Good understanding of MDR remediation; extensive cross-functional team experience, including technical and non-technical work.
Completely proficient in relevant products or process development processes.
Ability to organize and present technical and project management. overviews without assistance.
Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
Ability to manage routine small projects without assistance.
Investigate and analyze customer service problems and design improvement suggestions. Recommend design improvements.
Requirements:
Knowledge of the basic principles in various engineering disciplines.
Must have initial training in concepts of
Six Sigma
quality techniques.
Must know how to effectively run projects, coordinate contractors, and direct the activities of a technician
BS in Engineering (discipline: Mechanical, Biomedical)
3-5 years of experience in Medical Device Product Development (NPD), design control or change controls, DHF remediation, and product risk files. Medical device related to Bio surgical products (experience with Class II & III).
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