Selexa Biotech are exclusively partnered with a leading Medical Device manufacturer, who is looking to appoint a Mechanical Design Engineer to support business needs through design development and product improvement activities. You will be responsible for delivering technical expertise which ensures regulatory compliance and timely completion of development projects as well as exploring development opportunities within this specific technology and market.
RESPONSIBILITIES OF THE ROLE:
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 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.
Design & Development responsibility:
• Identify opportunities for research and development projects.
• Plan and coordinate own workload to brief provided.
• Generate concepts to meet both det...