Our client leading Medical Device Manufacturer is currently looking to appoint a Design Engineer who will be responsible for Supporting business needs through design development and product improvement activities. Delivering technical expertise which ensures regulatory compliance and timely completion of development projects and exploring development opportunities based on market / user needs, and technology research.
Support business needs
- Create and review technical design documents.
- Generate test protocols, perform, and document product testing.
- Provide technical input and support required by external functions (such as Corrective Action Support, Root Cause Analysis, Document / Process Change Requests, Regulatory Intelligence etc)
- Ensure compliance of products and technical documentation (ISO13485, ISO 14971, EU MDR (class Ir – IIa), FDA 21 CFR 820) and Summit Medical Ltd.'s internal Quality Management System
- Assist in the management of OEM customer relationships.
- Technical contact for customer communications
- Support existing product lines where required.
- Give technical support on the product portfolio to other departments across the business.
Product development activities
- Identify opportunities for research and development projects.
- Plan and coordinate own workload to brief provided.
- Generate concepts to meet both detailed, and open briefs.
- Create and maintain 3D CAD data and drawings.
- Identify most suitable means to prototype concepts and prove design principles.
- Assist in the implementation of product change.
Project Responsibilities
- Ensure project documentation is prepared and approved as per the requirements of the internal quality management system.
- Ensure timely completion of work.
- Plan and coordinate own workload to brief provided.
- Plan and execute product testing, including documenting, analysing and presenting data.
- Liaison with project teams, customers, and suppliers
Departmental Responsibilities
- Maintain R&D laboratory and ensure equipment is adequately stocked and functioning correctly.
- Implement departmental objectives.
- Carry out all role responsibilities in accordance with regulatory compliance requirements for medical devices (ISO13485, ISO 14971, EU MDR (class Ir – IIa), FDA 21 CFR 820) and internal QMS.
- Support R&D department with other duties as required.