Design Assurance Engineer II

Job Title:
Design Assurance II
Location:
Galway
Industry:
Medical Device
Company information:
World leader in medical device manufacturing
Role Profile
Cregg are hiring for an experienced Design Assurance Engineer to join a leading Medical Device company in Galway.
Key Responsibilities of the Role:
Working under the guidance of the Principal Design Assurance Engineer, the key responsibilities are outlined below:

• Is an active team member completing quality deliverables associated with BSC’s new product development and enterprise  value improvement projects support.
• Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Project Management, Operations, Supplier Engineering/Supplier Quality, Analytical Lab and Post Market Quality Assurance team environment, across multiple global sites, to provide technical and quality systems input.
• General:
  • Supports stability studies from start to finish (development of stability protocol, collaboration with the analytical lab for stability results from different timepoints, stability datasheets, stability data verification, development of stability report etc.)
  • Develops stability graphs on Minitab
  • Knowledge of stability programs, shelf life studies and ICH guidelines
  • Supports the approval of FDA pre-sub, FDA and DEKRA submissions
  • Knowledge of materials (polymers and metals), drugs, sterilization of medical devices.
  • Concludes and makes appropriate decisions from test data using excellent analytical and problem-solving abilities
  • Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
  • Provides design quality support in resolving PIRs, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
  • Seeks to support improvements in product and process quality.
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements.
• Design Control:
  • Understanding of Design Assurance requirements to support marketed product, product development, design changes and technology transfers and to ensure activities comply to all internal and regulatory requirements.
  • Provide detailed assessments of impacts for design and process changes on commercialized products
  • Collaborate in development and execution of Design Verification plans, protocols and reports for new and commercialized products as a member of multi-functional team activities through the life cycle of the product from concept, development, commercialization and end of life phases
  • Assure quality and completeness of documentation associated with design verification studies (including test data, manufacturing records, investigations, deviations, test method development, build plans) and generate submission packages in conjunction with Project Teams and Regulatory Affairs for regulatory submissions.
• Risk Management:
  • Familiarity with requirements of ISO 14971
  • Manage and update the product’s risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
• Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WIs and EU/FDA/Global guidelines.
• Support internal and external audits and audit responses for commercialized and new products.

 
 
Qualifications and Experience:

• NFQ Level 8 qualification in a STEM discipline
• Minimum of 2-3 years experience in a Design Assurance/Quality/R&D/Production capacity.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• You have a proven ability to work well both as part of a team and work on your own with minimum supervision.

Contact Information
For a confidential discussion or to find out more, please contact:
Mark Halligan
Email: Mark Halligan@cregg.ie
Phone: 0861901346