Job ID: JOB-11790
The R&D Engineer will design, develop, modify and evaluate medical devices. The engineer will use structured engineering, problem-solving and statistical techniques to designs and develop new products and/or improve existing products whilst adhering to regulatory requirements, project deadlines and budget.
Role & Responsibilities
- Design and set-up experiments, manage evaluation testing and work with suppliers/manufacturers in developing new and existing products.
- Actively involved in specifying, sourcing, testing and approving material
- Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents
- Project manage transfer of products from concept/design phase to commercial manufacturing
- Follow design control procedure/standards in accordance with ISO13485
- Create and maintain design-related technical notes (notebooks, protocols, validations, manufacturing documents, etc.) building a complete design history file
- Compile and analyse operational, test and development data to establish performance standards for newly designed or modified products
- Manage and prepare engineering test protocols and reports
- Provide new design concepts
- Work with relevant functions in transferring R&D projects to commercial operations.
As the successful candidate, you will have the following:
- Qualified to Level 8 in engineering, science or related discipline with a minimum of 4 years relevant experience
- Strong mechanical design skills
- Experience with design control and ISO1348
- Strong computer Skills in MS Word, Excel, Outlook, Project, etc.
- Six sigma green belt experience preferable
- Knowledge of catheter manufacturing processes essential
- Knowledge of material properties
- Strong project management and leadership skills essential
- Experience in risk assessment and FMEA
- CAD experience preferable
- Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.)
- Knowledge of catheter manufacturing processes (bonding, moulding, etc.)
- Experience in bringing a product from concept/design phase to commercial manufacturing
- Understanding/working knowledge of relevant standards and regulatory requirements
- Good working knowledge in statistical process control and capability analysis
- Good working knowledge in statistical process control and capability analysis using DMAIC and DOE techniques
- Influential team member, fully motivated to achieve and demonstrate best practices
For further information on this role please contact James Corcoran on 086 046 2367 / firstname.lastname@example.org
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