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Device Analytical Scientist

Location: Dublin
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Food Scientist, Quality Engineer

Device Analytical Scientist

Life Science Recruitment are sourcing a Device Analytical Scientist for our clients internal Global Device Development organisation who are focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for generic and branded global products. This organisation develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products. The succesful candidate will have the opportunity to work across the organisation to support innovative technology solutions and to provide healthcare solutions for patients worldwide.

The successful candidate will join the Device and Product Performance Group within Global Device Development as a Device Analytical Scientist.

Roles & Responsibilities

  • Performs mechanical and functional testing on medical devices and combination products using standard and bespoke techniques to meet requirements of device testing strategy.
  • Work with the team to set up a new device testing laboratory in Dublin. installation and qualification of new equipment including performing daily and monthly calibrations.
  • 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 design and development group.
  • Review and interpretation of 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 both internally within GDD to support design control on a range of device programs.
  • Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements.
  • Performing method validation and verification activities to support product testing.
  • Performing device investigations and participate in GDD and technical investigation teams as required. Reporting and logging of aberrant results using Trackwise™. Troubleshoot instrumentation and investigate aberrant sample results.
  • Maintaining a high standard of GMP in line with the GDD QMS ensuring audit readiness at all times.
  • Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.

Skills & Qualities

  • Degree in Science/Engineering with 3-5 years 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.

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

Simon Gillivan | Tel: +353 (0) 1 507 9258


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