Programme Manager - Medical Devices

Brightwater

Waterford

This is your chance to be part of the development of an exciting pipeline of new products. You`ve already worked on all aspects of the creation of new medical devices under the ISO 13485 standards; from product design and development through to validation and product launch. You love the idea of working for a small, dynamic company at the forefront of developing it`s technology; efficiently managing your time and hitting project milestones as you advance from idea generation through to commercialisation. Overview: Work closely with the R&D Director to implement the company’s strategy and achieve its business goals. Ensure that technologies, products and devices are developed to comply with relevant regulatory standards and CE certification requirements. Coordinate transfer of R&D projects to pilot & series manufacturing and be familiar with all related quality and regulatory protocols necessary. Support marketing to ensure timely product launches and manage the company’s training programme to train clinicians and customers on how to effectively use the company products so as to secure and accelerate product adoption in the market. Contribute as required to the development of company strategy and future business plans. Responsibilities: Reports to the R&D Director. Supervision of R&D department, staff and facilities. Develop NPD project plans with stakeholders. Update, maintain and monitor project plans in line with company objectives. Works to achieve goals and objectives as defined in R&D project plans. Carry out D&D activities, procedures, FMEcA, Risk analysis etc. Material development, testing and characterisation. Product/device development at all phases (idea generation through to commercialisation. Control and preservation of proprietary and third party intellectual property. Ensure that all intellectual property generated is captured, stored, and protected. Liaison with Clinicians, Customers, Universities, Institutes, suppliers and commercial organisations when required. Coordinate clinical studies and trials. Conduct training workshops with clinicians and customers. Support marketing. Prepare ongoing progress reports on a monthly basis or as requested. Liaise with appointed consultant(s) and person(s) with overall responsibility for quality and regulatory affairs. Monitor regulatory issues relating to medical devices under development. Prepare patent drafts with validated information and specifications. Responsible for implementing systems and procedures to satisfy the requirements associated with R&D grant scheme applications and subsequent claims. Ensure that NPD development is compliant with the company’s regulatory and quality systems, procedures, documentation and CE marking criteria. Generation and control of documentation for design history and technical files etc. Is willing to travel if required for the company. The ideal candidate will have a minimum of a relevant Science or Engineering Degree plus a number of experience leading a small R&D team to bring Medical Devices through all stages of development. Knowledge of Design History Files, IP and Patents and Design for manufacture is relevant.The ability to converse with confidence with relevant stakeholders including clinicians and customers is a huge advantage. For more on this role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

2619 days ago