Education / Educación: Bachelor’s Degree in Engineering or a similar career. Mechanical Eng, Electromechanical Eng, Chemical, Biotec Eng desirable
Experience / Experiencia: 2-year experience minimum as a technical field professional and in similar positions.
Specialized Knowledge (Desirable) / Conocimiento especializado (preferible): Experienced with Product and process Control requirements, ISO 13485 and Medical Devices Directive. Experienced with ISO 14971, Risk Management. Ability to effectively work with teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution. Strong ability to assess risks to define appropriate in-process controls, ensure thorough documentation as a principal advocate for compliance, and effectively communicate risk assessments to stakeholders. Knowledge of root cause failure analysis, statistical methods, and design of experiment. Competency i...