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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Director, Device Design & Industrialisation


Reference:JCOA11010 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: R and D Director, R and D Manager



Director, Device Design & Industrialization



Our client a Global Healthcare organization focused on the design, development and commercialization of a diverse portfolio of device technology solutions to enable delivery of a large and growing range of generic and branded products around the globe. The technologies they develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and they work across various sites to support innovative technology solutions to deliver healthcare to patients.


Role/Responsibilities

  • Manage the Device Design and Industrialisation team within Device Development group; contribute to the personal and professional growth and development of all colleagues within the team.
  • Lead design and engineering development of devices to enable drug-delivery for respiratory, biologic, biosimilar and injectable products
  • Implement Design for Manufacture (DFM) and scale-up devices for use in clinical trials and commercial supply.
  • Provide engineering expertise to external partners/suppliers in the industrialisation, scale-up and verification of device design.
  • Deliver design solutions within a regulated environment and lead engineering development whilst delivering the Quality Objectives defined within the QMS
  • Ensure all device & drug-device combination products are developed consistent with global design control and device requirements for such products.
  • Contribute to strategy developed across to support delivery of a robust device CMC program for global registrations within an appropriately risk-managed but aggressive timeline.
  • Actively promote a culture and environment where quality and compliance is the most important aspect in technical delivery, whilst using state of the art design processes to create superior combination products
  • Prepare detailed design reports to support overall device development.
  • Interface with internal & external partner groups to ensure an integrated approach to technical delivery and timelines for overall project execution
  • Contribute to strategic and technical elements of the wider R&D product development program aligned with experiences and technical expertise


Skills/Experience

  • Extensive experience in a mechanical engineering environment, with a substantial period in a device design leadership role.
  • Supervisory/Management experience in leading other engineers to deliver device design solutions.
  • Strong mathematical and mechanical engineering background, ability to solve and design engineering solutions from first principles
  • Proficient in engineering risk analysis techniques (e.g. FMEA) and their application in device design
  • Knowledge of device design controls and ISO/FDA requirements as applicable to device design.
  • Knowledge of the impact of industrialisation and scale-up of device manufacturing processes in device development.
  • Substantial experience working in the pharmaceutical industry in the development of devices for drug delivery.
  • Degree in mechanical engineering, or equivalent
  • Excellent communicator; clear and concise in communications with internal and external partners.
  • Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals.
  • Attention to detail in working approach
  • Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the group.

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