Principal Device Development Assurance Scientist/Engineer (18 months Fixed Term Contract)
Solicitar locations Northern Cross, Dublin, Ireland time type Tiempo completo posted on Publicado hace 23 días job requisition id R5655950 McDermott Laboratories Limited
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.
The Role & What You Will Be Doing
Every day, we rise to the challenge to make a difference and here's how the Principal Device Development Assurance Scientist/Engineer role will make an impact:
- Support and provide guidance for device development programs through the design and development lifecycle for Combination products, including prefilled pens, prefilled syringes, autoinjectors, and medical devices, by ensuring compliance to design control requirements outlined in Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971).
- Establish, maintain and provide guidance on the contents of Design History Files for development programs, for various program types – in-house design authority, collaborative development, and acquired programs; this shall include associated activity plans and timelines.
- Collaborate with, and influence, affiliate Viatris sites, collaborators and third parties to ensure appropriate objective evidence and controls are established and maintained in line with program deliverables.
- Support the integration, and assess compliance with design control requirements, of acquired combination products and medical devices, into the Global Device Development product portfolio.
- Support Risk Management activities for development programs through the implementation of ISO 14971:2019.
- Participate in third party audits – including Global Corporate Auditing, Health Authority Audits, Certification Body audits.
- Maintain awareness of ongoing industry best practices, new QSRs and QMS requirements as they are developed, and implement improvement actions for the QMS.
- Collaborate and support Health Authority submissions as required.
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:
- Education – Degree / Masters in engineering or science/life science
- Industry – Medical Device or Pharmaceutical (with devices)
- Min 5-7 years in similar level/ or 5-10 years general experience in industry
- Direct experience of device development and manufacturing operations activities for device or drug/device systems in a GMP environment
- Experience in the implementation of device design controls and ISO/FDA requirements as applicable to device design
- Demonstrated understanding of in GMP, Quality Management System, and relevant Regulations (e.g. 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745) and International Device Standards (e.g: ISO13485, ISO14971)
- Strong problem solving and analytical skills
- Possess knowledge of core manufacturing / laboratory operation principles
- Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines
- A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business
- Demonstrated ability to perform in a high-performing workforce
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.
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.
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