Principal Scientist/Engineer, Device and Product Performance page is loaded
Principal Scientist/Engineer, Device and Product Performance
Solicitar locations Northern Cross, Dublin, Ireland time type Tiempo completo posted on Publicado hace 5 días job requisition id R5660475 McDermott Laboratories Limited
En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.
Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.
Lo hacemos a través de:
Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;
Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;
Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.
Our Global Device Development is an innovative, technically-excellent and fully integrated organization, delivering access to high quality, safe, robust and effective device and combination products to meet the worlds’ evolving patient healthcare needs. 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.
Every day, we ris e to the challenge to make a difference and here’s how the Principal Scientist /Engineer (Device and Product Performance), an SME role in Global Device Development, will make an impact :
Key responsibilities for this role include:
* Provision of subject matter expertise to support the development of Combination Products
* Leading a team to plan and execute design verification and reliability strategies.
* Responsible for technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device development.
* Responsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirements.
* Responsible for developing test methods and specifications to assess device functionality and product performance including e valuat ion, procurement & implement new, state-of-the-art lab testing equipment as applicable.
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification .
* Provide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plans .
* Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliabilit y.
* Ensures all activities within team are conducted and executed to the appropriate quality standards within the GDD Quality Management system.
* Lead support activities for e xternal and internal audits and inspections as applicable.
The minimum qualifications for this role are:
* Degree in Science /E ngineering (Master’s preferred)
* Proven experience in pharmaceutical and/or medical device development
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage
* Experience in the development and validation of analytical methods
* Experienced in application of statistical techniques for data analysis
* Experience of writing and supporting regulatory submissions
* Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert role .
* Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders .
* Some travel will be required as part of this role .
At Viatris, we offer competitive salar ies, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.
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