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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.

• 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.

• 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

Life Science Clinical Research BD Manager Microbiology Analyst Validation Engineer EHS Specialist Chemist Quality Assurance Officer Supply Chain Regulatory Affairs Specialist Dublin Design Engineer Sales Development Executive Cork Business Development Engineering QA Analyst Waterford QA Executive Formulation Scientist Regulatory Affairs Executive Medical Device BD Executive Microbiology Lab Supervisor Quality Manager Microbiologist Product Specialist Biotechnology Food Scientist Business Development Manager QA Manager Scientific Sales Kildare Dublin City Centre QA Director Project Lead Supply Chain Supply Chain Coordinator QA Specialist Quality Control Manager Dublin South Chemistry Research and Development Scientist Regulatory Affairs Limerick Supply Chain Specialist PhD EHS Engineer Principal Scientist Research and Development Business Development Executive Sales Manager Quality Control Supervisor Project Engineer Regulatory Affairs Manager Equipment Engineer Process Development Engineer Pharmaceutical Contract Engineering Process Engineer Contract Manufacturing Coordinator Production Supervisor Dublin North Quality Assurance Supply Chain Administrator Regulatory Affairs Officer Scientific Microbiology Manufacturing Executive Nurse Associate Medical Affairs Life Science Automation Engineer Senior Research and Development Engineer Sligo Molecular Biologist Regulatory Affairs Director Connected Health Qualified Person Planner Biopharmaceutical Regulatory Affairs Account Manager Scientist Medical Advisor Dublin West Formulation Chemist Healthcare Republic of Ireland Research and Development Engineer Hospital Sales Rep Galway Sales Executive QA Supervisor