Design Assurance Engineer, Medical Devices & Compliance

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

Viatris is seeking a Design Assurance Engineer for Device Technical Operations in Ireland. You will oversee the creation and maintenance of Technical Documentation for development and on-market devices, ensuring compliance with ISO 13485, MDR, and FDA design controls.

The role requires experience in GMP environments, strong problem-solving and planning skills, and the ability to collaborate across site teams. Travel between global teams and suppliers may be necessary.

Qualifications

• Degree in Engineering/Science.
• Experience in Design Assurance for devices or combination products.
• Experience documenting technical reports in GMP/regulatory environments.
• Knowledge of MDR 2017/745, ISO 14971, ISO 13485 & FDA 21 CFR Part 820 design controls.

Responsibilities

• Provide Design Assurance oversight for Technical Documentation supporting development and on-market devices/combination products.
• Oversee transfer of manufacturing from R&D to commercial sites per GDD design control process.
• Manage, review, and approve change controls that impact the device/combination product.
• Provide on-site Design Assurance support for supplier/manufacturing site investigations and root-cause analyses.

Skills

Design Assurance

Technical Documentation

Regulatory Compliance

Quality Management

Problem Solving

Education

Degree in Engineering/Science

Job description

Viatris is seeking a Design Assurance Engineer for Device Technical Operations in Ireland. You will oversee the creation and maintenance of Technical Documentation for development and on-market devices, ensuring compliance with ISO 13485, MDR, and FDA design controls.

The role requires experience in GMP environments, strong problem-solving and planning skills, and the ability to collaborate across site teams. Travel between global teams and suppliers may be necessary.