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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Program Manager - R&D New Product Introduction


Reference:JCAO1223 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed


Program Manager – R&D New Product Introduction




Our client a medical device multinational is currently seeking an NPI Program Manager to join the team. The Program Manager will support the production of a cutting edge through development, verification, validation, clinical trials, and regulatory approval. Working closely with R&D, Clinical and Quality, the focus of this role will be on the implementation of the manufacturing strategy for a transcatheter heart valve delivery and anchoring system, including management of stock, supply-chain, and sub-contract manufacturer. Reporting to Technical Operation Director the Program Manager will initially ensure implementation of a manufacturing set-up fit for purpose for First-In-Man studies at the sub contractor manufacturers . Thereafter focus will be on managing projects to execute scale up of production, covering transfer of design and supply-chain management whilst ensuring product and project risks are appropriately documented, tracked and controlled / mitigated.


Role/Responsibilities
  • Provide PM and technical leadership for the manufacture of the support catheter system for First-In-Human Clinical studies.
  • Review and manage updates to all manufacturing documentation: MPIs, DHRs, in-process / manufacturing specs, BOM, Flowchart, DMR throughout DV for FIH, in-line with Change Control.
  • Freeze manufacturing documentation prior to DV builds. Execute Change Control for process updates, as required, through DV for FIH.
  • Update and manage system for stock at both CroiValve and SCM site.
  • Supply Chain management, including qualification and generation of development and commercial agreements. Maintain ASL.
  • Project manage manufacturing activity at SCM in support of FIH and subsequently scale up for larger clinical studies.
  • Identify and work with SCM and suppliers to source equipment appropriate to facilitate the robust manufacture of catheter systems, with verifiable processes both for manufacture and inspection.
  • General project management of all manufacturing activities at sub-contract manufacturer, including communication of instructions to SCM operations.
  • Provide project updates to senior management.
Subsequently in support of technical design transfer
  • Develop project plans, risks, budgets, timelines and resource requirements to facilitate scale up of activity to support increase production for clinical studies
  • Ensure sufficient transfer of supply chain and manufacturing documentation to SCM as required as part of scale up activity
  • Generation of demand forecast to support clinical studies; working closely with suppliers and SCM to ensure demand can be met reliably.
  • Support SCM in set-up of manufacturing and in identifying resource needs. Support key decisions, impacting costs and timelines, with scenario planning to ensure favourable outcomes.
  • Implementation of robust supplier performance and monitoring processes.
  • Ensure voice of suppliers/SCM is integrated into new design iterations
  • Support and consult on all process validation activities as required.
  • Responsible for the capture of product and project risks and maintenance of risk register.
  • Support implementation of development and commercial supply agreements with SCM.
  • Technical support to SCM for issue resolutions with component level suppliers.
  • Support audits of SCM and support supplier as required when auditing their supply chain.




Skills/Experience
  • Degree or masters degree in mechanical engineering, or related discipline.
  • 7-10 years experience in medical devices, with a minimum of 3 years in Project management of technical projects across R&D and Manufacturing. The projects should incorporate new product introduction, preferably in cardiovascular devices, in particular catheter delivery systems.
  • Experience managing and collaborating with external SCMs.
  • Project management skills - capable of operating and liaison at all levels including managerial, project and technical. Proven track-record in planning and resource management to meet defined project goals. Experience with processes to identify and control risks within the project. Ideally PMP or Prince 2 certified or holds similar qualification.
  • Broad knowledge of materials and manufacturing processes applicable to medical device industry is desirable.
  • Demonstrated analytical problem-solving abilities to resolve complex technical issues. Ability to consume, analyse and structure information from numerous sources and stakeholders into clear formats to support communication, key decision-making and strategic planning.
  • Experience working with suppliers and vendors, including qualification and ongoing performance monitoring.
  • Experience of preparing technical documentation for manufacturing support and to support submissions
  • Excellent communication, organisational and time management skills.
  • Previous experience in start-up environment is a plus.


The location for this role in flexible and open to discussion. The role will initially require the successful candidate to be onsite in Dublin 2-3 days a week as part of onboarding to familiarise themselves with the product and the team. Thereafter the role can be a combination of on-site and remote working. The role will involve up to 20% travel pa to key suppliers.



For further information please contact James Cassidy [email protected] or call in confidence 0860204322