Summary: The Mechanical Design Engineer role involves product design and development of medical devices, overseeing projects from concept to market release. The position is within a rapidly expanding company that specializes in medical devices, offering significant growth opportunities. The engineer will be responsible for compiling design documentation and ensuring compliance with industry standards. This is an excellent opportunity to join a stable organization with a strong global presence.

Key Responsibilities:

• Product design and development of medical devices from concept to market release.
• Compile DHF including product design, specifications, DFMEA, design testing, verification, validation, and usability.
• Lead project actions in the UK and with manufacturers for design transfer.
• Provide engineering requirements for ECOs and maintain allocated legacy DHFs.
• Verification and validation of components and assemblies, including ISIR and appropriate testing.
• Record all formal and relevant informal engineering information in the PLM system.
• Modify/amend new/existing drawings in accordance with design standards.
• Perform other reasonable duties as requested by the manager.

Key Skills:

• Problem-solving techniques (DFMEA/Risk Analysis).
• Experience in compiling usability engineering files.
• Experience as a Design Engineer within a manufacturing environment.
• Design requirements for extruded/moulded parts.
• Understanding of ISO13485:2003/MED DEV 93/42/EEC and/or FDA regulations.
• Experience with Product Life Cycle Management Systems and/or ERP Systems.
• Bill of Materials creation and management.

Salary (Rate): undetermined

City: Aberdare

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other