Design Assurance Engineer 3 CR

• Provide design assurance support for new product development and on market medical devices.  This role will be responsible to facilitate the application of design controls while supporting product development, 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 independently on design changes and other sustaining projects, assuring product inputs are clearly defined and assuring design verification and validation activities are appropriate and compliant to confirm inputs requirements are met.  Test method validation would be an element of assuring verification/validation is acceptable..
• Work collaboratively with R&D to coordinate design elements of Risk Management files for product to assure compliance with applicable standards and internal policies.
• Assess nonconforming product evaluations and use-as-is concessions for adequacy and impact on customers

• Experienced with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485 and Medical Devices Directive.
• Experienced with ISO 14971, Risk Management.
• Familiarity with Usability, Reliability, Electrical Safety, Software, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of requirements analysis, including development of testable and measurable specifications.
• Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution.
• Ability to appropriately assess written product and project documentation as the principle advocate for compliance, and ability to effectively communicate assessment.

• Preferred: Working knowledge of test method validation, root cause failure analysis, statistical methods, and design of experiment.

   

  Languages ​​required for the position (Desirable): Spanish/ Fluent English