Device Development Assurance Scientist

at  Viatris

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.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
The Role & What You Will Be Doing
The Design Assurance Engineer will be responsible for supporting post market activities for the Viatris combination products and medical device portfolio, within the Global Device Development group. We are seeking an individual who promotes Cross-Functional collaboration and is capable of working independently on projects with stakeholders both internal and external to the Global Device Development group.
Every day, we rise to the challenge to make a difference and here’s how the Device Development Assurance Engineer role will make an impact:

The Design Assurance Engineer/Scientist role is primarily responsible for supporting the life-cycle management (LCM) activities for Vaitris combination product and medical device programs that are:

• In the post-production phase
• Transitioning from development phase into the post-production phase
• Acquired by Vaitris and require integration into the GDD QMS
• DHF documentation gap analysis, review and updates to GxP requirements.
• Ensuring compliance to EU MDR/FDA regulations by maintaining awareness, and application of: ongoing industry best practices, relevant regulation/standard changes, GxP requirements.
• Participation in various design quality assurance and compliance improvement, continuous improvement projects in conjunction with the QMS team, cross functional development teams, and Global sites (when required).
• Support internal cross functional development team group, and Global external teams , through product life cycle process; with respect to design control, and risk management deliverables for post production programs.
• Support the CAPA process, including identifying root causes, developing and implementing corrective actions, verifying the effectiveness of actions taken, and ensuring timely closure of CAPAs in compliance with quality management systems and regulatory requirements.
• Supporting the execution of Internal Audits, third-party inspections/audits, and corporate Quality audits

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree in Engineering or Biotechnology
• Minimum 2-3 years relevant professional experience (GMP / Medical Device /Risk Management/Post Market)
• Demonstrated ability to perform in a high-performing workforce
• Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745
• Strong problem solving and analytical skills
• Possess knowledge of core manufacturing / laboratory operation principles

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

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. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
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.

The Design Assurance Engineer/Scientist role is primarily responsible for supporting the life-cycle management (LCM) activities for Vaitris combination product and medical device programs that are:

• In the post-production phase
• Transitioning from development phase into the post-production phase
• Acquired by Vaitris and require integration into the GDD QMS
• DHF documentation gap analysis, review and updates to GxP requirements.
• Ensuring compliance to EU MDR/FDA regulations by maintaining awareness, and application of: ongoing industry best practices, relevant regulation/standard changes, GxP requirements.
• Participation in various design quality assurance and compliance improvement, continuous improvement projects in conjunction with the QMS team, cross functional development teams, and Global sites (when required).
• Support internal cross functional development team group, and Global external teams , through product life cycle process; with respect to design control, and risk management deliverables for post production programs.
• Support the CAPA process, including identifying root causes, developing and implementing corrective actions, verifying the effectiveness of actions taken, and ensuring timely closure of CAPAs in compliance with quality management systems and regulatory requirements.
• Supporting the execution of Internal Audits, third-party inspections/audits, and corporate Quality audit

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree in Engineering or Biotechnology
• Minimum 2-3 years relevant professional experience (GMP / Medical Device /Risk Management/Post Market)
• Demonstrated ability to perform in a high-performing workforce
• Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745
• Strong problem solving and analytical skills
• Possess knowledge of core manufacturing / laboratory operation principle