Summary of Duties and Responsibilities : Provide design assurance support for on market medical devices. This role will be responsible to facilitate the application of design controls while supporting manufacturing related design changes, maintaining regulatory compliance, implementing improvements for manufacturability and evaluating cost reduction efforts.
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Participate on sustaining product projects with support of lead / manager, assuring project is clearly defined and stays on task, confirming product inputs are continuing to be met, and necessary verification, validation, and risk management activities are completed.
Assess change requests of product for impact to design, determine supporting information required for implementation of changes.
Demonstrate initiative, balanced assertiveness working as a team player. Ability to effectively work on project teams. Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment
Education : Bachelor Degree life sciences, engineering or related discipline.
Experience : Previous experience is not required.
Specialized Knowledge (Desirable) : Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485 and Medical Device Directive
Languages required for the position (Desirable) : Spanish / English
Computer tools and knowledge level required (Desirable) :
Microsoft Office Word, Excel