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ViatrisDesign Assurance Engineer, Device Technical Operations ( 18 Months FTC )
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Before you apply
LocationNorthern Cross, Dublin, Ireland
Work modeon-site
Typefull-time
SeniorityMid
DepartmentDevice Technical Operations
Company size10,000+ people
PostedAug 24, 2026 · 2mo ago
Verified live1d ago
At a glanceSummarised by Seekless from the posting.
Degree in Engineering/Science
Previous experience of Design Assurance in device development or high volume GMP manufacturing environment for devices and/or combination products
Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment
Experience in quality management, ideally in the medical device industry or another regulated environment
Highly innovative and well organized, having excellent planning and communication skills
Able to work under pressure and have a proven track record of problem solving and effective time management
Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers
A working knowledge of MDR 2017/745, ISO 14971, ISO 13485 & FDA 21 CFR Part 820 Design Control requirements
Skills
ISO 13485
FDA 21 CFR Part 820
ISO 14971
MDR 2017/745
Benefits
Health insurance
401(k)
About the company
McDermott Laboratories Limited
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
About the role
Every day, we rise to the challenge to make a difference and here’s how the Design Assurance Engineer, Device Technical Operations role will make an impact:
Responsibilities
Key responsibilities for this role include:
•
Provide Design Assurance oversight and support to the creation and maintenance of Technical Documentation supporting development and on-market combination products / medical devices.
•
Provide Design Assurance oversight for the transfer of manufacturing of Devices and Combination Products from the Global Device Development (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.
•
Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.
•
Provide Design Assurance support on site as required at suppliers or manufacturing sites for device-related complaints, support device-related investigations to root cause and the establishment of appropriate corrective actions.
The minimum qualifications for this role are:
•
Degree in Engineering/Science
•
Previous experience of Design Assurance in device development or high volume GMP manufacturing environment for devices and/or combination products.
•
Experience authoring technical reports and producing high quality documentation within a regulatory controlled GMP environment.
•
Experience in quality management, ideally in the medical device industry or another regulated environment
•
A working knowledge of MDR 2017/745, ISO 14971, 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 organized, 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.
•
Willingness to travel as necessary between the Global Device Development Teams, Affiliates & suppliers.
Benefits
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.
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.
Legal
Viatris is an Equal Opportunity Employer.