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Senior Device Development Engineer

Job Seekers Ireland Engineering, Science Life Science, Pharmaceutical

Job Summary

  • Dublin
  • Permanent
  • BBBH790040
  • Aug 11, 2021
  • Competitive
Job Description

An excellent opportunity has arisen for a Senior Device Development Assurance Engineer to join a speciality pharmaceutical company based in Dublin.

This role will be a permanent position and it is a very exciting time to join the company as they have several new and existing projects ongoing.

The successful candidate will have minimum 3 years' experience working in a similar role in device delivery. You will have experience in Medical Device, Pharma with device or combination device. A solid understanding of ISO13495 and GMP is essential. Experience in design control and design assurance preferential. A degree in Biomedical, Mechanical or Science essential. This role will be remote to begin but the candidate must be flexible to be on site based on the business needs.

Responsibilities:

  • Support the device development programs through design and development lifecycle for combination and medical products through quality management systems, regulations, and international standards.
  • Maintenance of ISO13485:2016 QMS, internal audits, CAPAs, complaints while adhering to 21 CRF 820 and Medical Device Regulations.
  • Participate in external audits including corporate, health authority and certification audits.
  • Support risk management activities in line with ISO14971:2019.
  • Assess compliance with design control requirements into the global device development product portfolio.
  • Supporting technical transfers of products and processes into commercial manufacturing facility.
  • Collaborate with affiliate sites, collaborators, 3rd party to ensure objectives are established.
  • Support Health Authority submissions as needed.

If this role is of interest to you, please click 'Apply Now' or for more information contact Aoife on aodriscoll@morganmckinley.com or 021 2300 200.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Consultant
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com