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Associate Engineer, Device Technical Operations
1 week ago
Associate Engineer, Device Technical Operations
Associate Engineer, Device Technical OperationsApply locations Northern Cross, Dublin, Ireland time type Full time posted on Posted 2 Days Ago job requisition id R5657018 McDermott Laboratories Limited
At VIATRIS, we see healthcare not as it is but as it should be.
We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here's how the Associate Engineer, Device Technical Operations role will make an impact:
Key responsibilities for this role include:
Provide technical support for the transfer of manufacturing of devices and combination products from the GDD group in R&D to commercial manufacturing sites as per the GDD design control process in compliance with ISO 13485 and 21 CFR 820.
Author the Technology Transfer Plan and Report outlining the transfer of all required deliverables including equipment requirements and manufacturing and testing specifications.
Supporting knowledge transfer and training on relevant technical transfer activities to the commercial site.
Develop manufacturing process understanding by use of tools such as Cause and Effect, providing linkage to all aspects of manufacturing and utilized to identify any potential failures.
Perform trending of on-market complaint data through review and reporting of relevant complaint databases.
Supporting supplier management activities, technical assessment of CMOs, manufacturing sites, packing sites etc and support the authoring of the technical assessment reports.
Support the device program teams with technical reviews across the GDD portfolio.
Proactively contribute through ownership of the deliverables of the quality objectives defined within the GDD QMS.
Adhere to ISO 13485 in line with the Global Device Development QMS ensuring audit readiness at all times.
The minimum qualifications for this role are:
Degree in Engineering/Science
Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment.
Previous experience of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
It is essential that the candidate will be both highly innovative and well organised, having excellent planning and communication skills and able to operate across all site teams.
The candidate must be able to work under pressure and have a proven track record of problem solving and effective time management.
Well-developed communication skills to lead or facilitate effective discussions.
Able to communicate technical and/or project information to key stakeholders.
Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers.
At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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