Design Assurance Engineer, Device Technical Operations ( 18 Months FTC )

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

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. 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:

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.

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.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.