Mechanical Design Engineer - Medical Devices (Hybrid)

Placements24; Paarl; Hybrid; ZAR 900,000 - 1,400,000; Full time

Benefits offered by this job

Health coverage

Retirement savings options

Professional development

Hybrid work model

Job summary

Placements24 client in Paarl, Western Cape, seeks a Mechanical Design Engineer to drive the design and development of state-of-the-art medical devices. You will contribute across concept, prototyping, verification and validation, ensuring regulatory alignment and design history documentation.

The role is hybrid, combining on-site collaboration with remote work, and requires a strong background in precision engineering, materials science, and regulatory standards such as ISO 13485 and FDA

Qualifications

• Bachelor's or master's degree in Mechanical Engineering or biomedical engineering.
• 5+ years in mechanical design and product development, preferably medical devices.
• Experience with 3D CAD and PDM systems.
• Knowledge of ISO 13485 and FDA requirements.

Responsibilities

• Design, develop, and test mechanical components and systems for medical devices.
• Create 3D CAD models and 2D drawings per medical device standards (ISO 13485).
• Perform stress, strain, and thermal analyses using FEA tools.
• Collaborate with biomedical, electrical, software, and QA teams.
• Support verification and validation activities to meet regulatory requirements.
• Develop and maintain DHFs, RMFs, and manufacturing docs.
• Troubleshoot design issues during prototyping and production.
• Research new materials, technologies, and manufacturing processes.

Skills

Mechanical design

Product development

Regulatory compliance

Cross-functional collaboration

Problem-solving

Education

Bachelor's or Master's degree in Mechanical Engineering or related biomedical engineering

Tools

SolidWorks

Inventor

PDM systems

FEA tools

Job description

Placements24 client in Paarl, Western Cape, seeks a Mechanical Design Engineer to drive the design and development of state-of-the-art medical devices. You will contribute across concept, prototyping, verification and validation, ensuring regulatory alignment and design history documentation.

The role is hybrid, combining on-site collaboration with remote work, and requires a strong background in precision engineering, materials science, and regulatory standards such as ISO 13485 and FDA