- Reference: GJ44084
- Job Type: Permanent
- Location: Connacht, Galway, Galway City
- Category: Engineering, Technical & Manufacturing
Overall Job Objective:
The purpose of this job function is to manage the R&D and Operations engineering and manufacturing for the development and production of new medical devices. This will involve the tasks outlined in the Duties and Activities below while playing a supporting role to other team members in the company. The Head of Engineering will work as a key member of the management team and product development teams. They will be integral in the development and implementation of innovative manufacturing processes and strategies for our medical devices technologies in accordance with the requirements of International Standards: EN ISO 13485:2003, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and our clients Medical Quality Management System.
Duties and Activities:
• Manage the execution of all Design Projects ensuring that sound engineering principles are employed to meet the required timelines and design intent.
• Ensure appropriate materials and technologies are investigated, selected and developed to deliver robust and reproducible designs, capable of meeting all verification, validation and user requirements.
• Ensure that Design for Manufacturability and product cost impact (materials and processing) are considered in all decision making right from early concept stage so as to ensure final design can be scaled seamlessly in to manufacturing at the required product cost for commercial success.
• Manage the concept and product development activities, including; CAD & 3-D modelling; generation of design solutions; generation of prototypes and development of detailed product specifications
• Ensure key deliverables such as Product spec definition, risk management definition and mitigation, test method development and validation, design verification and validation activities are executed successfully to support delivery of a robust design in full compliance with regulatory and commercial requirements.
• Ensure that inventions are documented and patent specifications/applications are drafted and filed as appropriate.
• Review and structure the department functions to ensure necessary resource levels, skills/knowledge and experience are present, contracted and/or developed to deliver on objectives.
• Plan, develop and implement strategy for operational management, so as to meet agreed organizational performance plans
• Manage design transfer into manufacturing.
• Select strong reputable vendors and implement sub-contract manufacturing technical agreements
• Manage manufacturing training activities
• Identify and implement changes that will improve the performance and manufacturability of a device
• Support the pre-clinical, clinical and commercialisation product requirements
- Third Level Qualification in Engineering or related discipline required.
- Relevant post graduate qualification desirable
• Minimum of 15 years medical device experience with a minimum of 5 years in the management of an R&D/ Operations function.
• Proven experience of working with and leading R&D & Operations teams through multiple medical device product development projects from concept to commercialisation.
• Experience of plastic part design for injection moulding and extrusion
• Strong knowledge of the EU and US regulations for the manufacture and supply of medical devices
• Experience in selecting and assessing vendors for medical device component production and assembly
• Experience in developing sub-contract manufacturing and technical agreements
• Excellent interpersonal organization and communication skills.
• Excellent analytical skills with experience in application of problem solving techniques, such as DOE & DMAIC to troubleshoot and resolve complex technical issues.
• In depth understanding of ISO and FDA quality system requirements for medical devices.
• Experience in project managing development projects.
• Knowledge and experience of state of the art materials processing techniques and associated technologies.
• Knowledge of clean-room manufacturing processes and methodologies
• Knowledge of Industrial Design.