Design Assurance Engineer

Recruiter
Aerogen Ltd.
Employment Type
Permanent
Salary
Not disclosed
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Design Assurance Engineer

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Aerogen is Ireland’s largest indigenous Med-tech company, we continue to rapidly grow our domestic and global presence and our Purpose and Ambition “to build a truly great global life science company that transforms patient lives through world-leading aerosol drug delivery” has never been stronger.

Aerogen is the world leader in Acute Care Aerosol Drug Delivery recognised through multiple MedTech awards and seven times winner of the Zenith awards for Respiratory Care Excellence in North America. We make a difference to patients’ lives every day, having already reached 14 million patients in over 75 countries.

Job Summary:

Working with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Software Validation, 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 independent reviewer for all design activities including design changes.
  • Support new test development and appropriate test method validation (TMV)
  • Technical reviews of Process Validation deliverables including IQ, OQ and PQ as well as input to computer system validation (CSV) where required.
  • 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.

Education/Experience:

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

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 Quality Systems.
  • Understanding of Design Control Process.
  • Proficiency in use of desktop software applications such as MS office, Word, Excel, PowerPoint.
  • Some travel may be required with the role.

Environmental Conditions: Typical office environments, with work also performed in R&D and test labs, and customer/supplier locations.

To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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