Principal Engineer Device Industrialization

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.

The Role & What You Will Be Doing

Every day, we rise to the challenge to make a difference and here’s how the Principal Engineer Device Industrialization role will make an impact:

• Lead industrialization design & procurement of new medical devices with a focus on respiratory and injectable drug delivery, drawing on insight into mass-produced mechanisms, design skills, creativity, initiative and drive.

• Technically lead design industrialization teams to realize solutions for complex mechanical drug delivery systems.

• Interface with the GDD Project Team and partner groups to ensure an integrated approach to overall project delivery.

• Management of Contract Manufacturing Organizations (CMO) and suppliers via technical visits for delivery of qualified tooling prototype to scale-up qualification against budget and project plan.

• Use knowledge of materials, high-volume component manufacturing processes and complex assembly processes to develop cost-effective and robust components/material selections and assemblies.

• Drive industrialization solutions based on solid engineering principles, calculations and tolerance analysis. Evaluate technical risks within a development and identify effective mitigations.

• Adhere to ISO 13485:2016 in line with the Global Device Development QMS ensuring audit readiness at all times.

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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:

• Degree in Engineering in Tool Design or related plastic injection moulding manufacturing.

• Minimum 6-8 years of experience in the design, manufacture, and management of tooling from single cavity to high cavitation injection molds.

• Experience of 3D CAD computer aided design, 2D drawing specifications, Geometric Dimensioning & Tolerancing (GDT)

• Practical knowledge of Statistical Process Control (SPC) and Design of Experiments (DOE) and Tolerance Analysis.

• Experience authoring technical writing/reports within a regulatory controlled GMP environment.

• A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.

• Experience in ISO 14971 Risk Management and Change Control Processes--document updates and document management would be an advantage

• Experience in device classifications 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 teams.

• 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.

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.

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

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.