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Details

Test Method Development Scientist


Reference:AWQO-216887 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Test Method Development Scientist
Our Dublin based client requires a Test Method Development Scientist to join their team on a permanent basis. This is an excellent opportunity to work cross functionally and gain in depth experience of device development.

Responsibilities
• Responsible for comparator product activities within the group, including building and maintenance of the physical and electronic library and comparator testing
• Perform mechanical and functional testing on medical devices and combination products using standard and bespoke techniques developed to meet requirements of device testing strategy
• Develop Design Verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines
• Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead
• Ensure all technical issues encountered are discussed with the relevant SMEs within the group
• Review and interpret analytical data in line with study and protocol objectives
• Compilation of technical reports to support design and development lifecycle.
• Represent the device and product performance group on cross functional teams to support design control on a range of device programs
• Work with external laboratories to ensure study protocols are executed in line quality and regulatory requirements
• Perform method validation and verification activities to support product testing
• Perform device investigations and participate in technical investigation teams as required
• Reporting and logging of aberrant results using Trackwise
• Troubleshoot instrumentation and investigate aberrant sample results
• Maintain a high standard of GMP in line with QMS ensuring audit readiness at all times
• Attend EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.

Requirements
• Degree in Science/Engineering in addition to relevant work experience in the medical device or pharmaceutical industry
• Previous experience of testing and working with medical devices and/or combination products i.e. Pre-filled Syringes or pen injectors is desirable
• Previous experience in laboratory equipment qualification and analytical method verification and validation is desirable
• Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820
• Design Control requirements would be an advantage
• Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks
• Some travel will be required as part of this role



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252