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:
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. Act as a technical contact for customer communications. Support existing product lines where required. Provide technical support on the product portfolio to other departments across the business. 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. 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. Initiate, support and lead Continuous Improvement projects as required. 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.
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RESPONSIBILITIES OF THE ROLE:
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. Act as a technical contact for customer communications. Support existing product lines where required. Provide technical support on the product portfolio to other departments across the business. 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. 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. Initiate, support and lead Continuous Improvement projects as required. 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.
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