Scientist/Engineer, Device Technical Operations (Analytical) …, Dublin Pike

The Role&What You Will Be Doing

Provide technical support 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.

Act as the interface between R&D and the commercial manufacturing sites during device/combination product development and provide support for the troubleshooting of all device related issues/investigations.

Manage, review, and approve change controls issued from the commercial site or from GDD which are deemed to impact the device/combination product.

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.

Provide technical support and act as technical SME 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.

Generate technical documentation to support medical device / combination product such as Device Requirements, Test Methods, Product / Purchasing Specifications, Design Verification Strategy / Protocols&Reports, Laboratory Investigation Support.

About Your Skills&Experience

Degree in Engineering/Science.

Previous experience of Technical Transfer and/or Technical Support in 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.

Working knowledge of MDR 2017/745, ISO 13485&FDA 21 CFR Part 820 Design Control requirements would be an advantage.

Highly innovative, well organised, excellent planning and communication skills and able to operate across all site teams.

Ability to work under pressure with 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.

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. You will also have the opportunity to access excellent career progression opportunities and work‑life balance initiatives.

Viatris is an Equal Opportunity Employer.

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