Design Assurance Engineer 1 CR (Temporary 12 months)

Design Assurance is the disciplined engineering process of assuring the requirements, qualification process and results are done in the proper way for the desired goal. Provide design assurance support for on market medical devices. This role will be responsible to facilitate the application of design controls while supporting manufacturing and design changes, maintaining regulatory compliance, implementing improvements for manufacturability, and evaluating cost reduction efforts.

• Education / Educación:

  • Bachelor’s degree in life sciences, engineering, or related discipline.

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferable):
  • Familiarity with FDA Quality System Regulations, especially Design Control requirements
  • ISO 13485
  • Medical Device Directive
  • EU Medical Device Regulation.

• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
  • Spanish/English

• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
  • Microsoft Office

Duties are listed in order of greatest importance:

• Support Health Risk Assessments when needed for evaluation of on-market products, demonstrating efficient and effective analysis of situations, including problem definition and impact.
• Support to internal and external audits while preparation and conduction, support to NCEs, CAPAs, SSEs, QPLs and other quality figures.
• Support business projects such as quality management continuous improvements, internalizations, supplier changes, and value improvement projects, all while assuring quality, compliance, and safety.
• Implementation and maintenance of Risk Management through product life cycle.
• Participate in sustaining product projects with the support of the lead/manager, assuring the 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 products for impact to design, and determine supporting information required for implementation of changes.
• Support to Post Market Surveillance department regarding complaint investigation, CERs/CEPs, and other PMQA activities.

The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned above as reasonably required by business needs.

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