Senior Design Engineer
Job ID: JOB-12537
Senior Design Engineer
The purpose of this Role is to plan and execute product development and design control activities associated with the development and commercialisation of innovative Medical Devices.
- Take on responsibility for the development of new products in line with the Product Development Process with particular focus on the definition, development, testing and validation of device components, assemblies and packaging.
- Execute product design activities ensuring that sound engineering principles are employed to meet design intent.
- Investigate, select and develop appropriate materials and technologies and associated specifications to ensure that final design is robust and reproducible and capable of meeting design intent and all verification and validation requirements.
- Generate and maintain required Engineering and Design documentation in line with the Quality Management System and associated regulatory 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.
- Organise and execute design control activities such as risk analysis, FMEA, product specification, test method development, sterilisation and ageing study development and design verification in order to successfully bring product to Design Transfer stage.
- Liaise and work effectively with Sales & Marketing, Regulatory, DA, QA, Planning and other critical functions to form a cohesive project Team ensuring all inputs and requirements are considered, included in project scope and executed to facilitate smooth and timely execution of projects minimising the risk of project creep or slippage.
- Leads New Product Introduction (NPI) process ensuring contract review, drawings, BOM’s and routers are completed
- The role will involve customer facing aspects, the person will need to be technically strong and have an ability to understand customer requirements on a wide range of products and translating those requirements in to specifications.
- Provide Guidance to Junior Engineers and Technicians within the R&D Department.
- Performs other related duties and tasks as required.
- Educational experience of a Bachelor’s Degree in Biomedical Engineering with a minimum of five years previous related experience and/or a Master’s Degree.
- Demonstrated track record in medical device product design & development from concept through commercialisation
- Demonstrated experience in Risk Management and executing Failure Mode and Effects Analysis
- Demonstrated experience of Metal and Plastic part design and processing
- Experience in Test Method development and Validation
- Strong analytical and problem solving skills
- Strong project Management skills
- Excellent Technical Report Writing skills
- 2D/3D CAD (preferably Solid Works )
- Knowledge of ISO 13485, MDD and applicable FDA requirements
- Experience in Product Development and the Product Development Life Cycle.
- Strong communication skills are essential.
- Ability to be self-motivated and self-driven.
- Flexible in terms of delivering value to customers.
For further information on this role please contact Tommy McKeown on 086 0100903 / firstname.lastname@example.org
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