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Design Assurance Engineer - Ireland  

Aerogen (company)


Posted on : 10 July 2017

Project Description

Job Summary
Working with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Product and Process Validation System, and Risk Management Activities.

Duties / Responsibilities
  • Performs Design Assurance activities including technical reviews of design documentation and labeling, attends at design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as an independent reviewer for all design activities including design changes.
  • Support new test development and appropriate validation
  • Quality approver on all relevant records, tests, validations, reports, project file entries etc
  • Implement updates to applicable quality system requirements.
  • QA lead for Product design transfer/validation strategy development and implementation.
  • Supports external audits including notified body and FDA audits.
  • Promotes the awareness of regulatory and customer requirements throughout the organization.
  • Methodical review approach and be capable of initiating and leading change and continuous improvement.

Specific Requirements
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate quality / regulatory concepts effectively.
  • Excellent understanding of ISO 13485 and FDA QS regulations.
  • Understanding of R&D stage gate process
  • Proficiency in use of desktop software applications such as MS office.
  • Some travel may be required for the role.

Education / Experience
  • A degree in Engineering, Technology, or Science
  • At least 3-5 years experience working in a regulated device or pharmaceutical company.
  • Excellent planning and coordination skills.
  • Excellent verbal and written communication skills.
  • Excellent attention to detail skills
  • Formal training in product risk management, problem solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous


Some of the benefits our employees enjoy:
  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi- Start Time.