Mechanical Design Engineer

Our client a leading Medical Device Manufacturer is looking to appoint a Mechanical Design Engineer to support business needs through design development and product improvement activities. Deliver technical expertise which ensures regulatory compliance and timely completion of development projects and explore development opportunities based on market / user needs, and technology research.

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.

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.

Continuous improvement - To initiate, support and lead Continuous Improvement projects as required.

Health & Safety - All employees are to be aware of and understand their health & safety responsibilities as laid out in the company’s Policy and its associated documentation. All employees have a legal duty to take all care needed for the safety of themselves and others who may be affected by their activities and to co-operate with the employer in complying with statutory requirements.

QUALIFICATIONS AND EXPERIENCE:

• Education: BSc, HND, HNC or equivalent in a medical, scientific, or engineering discipline. Engineering background (MechEng) desirable.
• Experience: Up to two years relevant experience in private sector role involving the manufacture of medical devices within a QMS (ISO 13485 and 21 CFR)
• Technical Skills: Knowledge of design and manufacturing within the requirements of the current medical device regulatory landscape
• Experience in 2D and 3D CAD packages (preferably SolidWorks) is beneficial.
• Personal Attributes: Self-motivated and organized. Effective verbal, written and interpersonal communication skills. Innovative and creative thinker. Good attention to detail.