Mechanical Design Engineer - Medical Devices

Our client, a pioneering company in the medical device industry, is seeking a dedicated Mechanical Design Engineer to join their innovative team in Paarl, Western Cape . This role is crucial for the design and development of state-of-the-art medical devices, requiring meticulous attention to detail and a strong understanding of precision engineering. You will be involved in the entire product development lifecycle, from concept generation and prototyping to verification and validation, ensuring compliance with stringent regulatory standards.

This hybrid role offers a balanced approach to work, combining on-site collaboration with the flexibility of remote work. Join us in making a significant impact on healthcare through innovative engineering solutions.

• Design, develop, and test mechanical components and systems for novel medical devices.
• Create detailed 3D CAD models and 2D manufacturing drawings compliant with medical device industry standards (e.g., ISO 13485).
• Perform engineering analysis, including stress, strain, and thermal analysis, using FEA tools to ensure design integrity and reliability.
• Collaborate with cross-functional teams, including biomedical engineers, electrical engineers, software developers, and quality assurance, throughout the product development process.
• Support the verification and validation activities of medical device designs, ensuring they meet intended use and regulatory requirements.
• Develop and maintain comprehensive design documentation, including design history files (DHFs), risk management files (RMFs), and manufacturing documentation.
• Troubleshoot mechanical design issues and implement effective solutions during prototyping and production phases.
• Research and evaluate new materials, technologies, and manufacturing processes relevant to medical device design.
• Ensure all designs comply with relevant FDA, CE, and other global regulatory body requirements.

• Bachelor's or Master's degree in Mechanical Engineering or a related biomedical engineering field.
• A minimum of 5 years of experience in mechanical design and product development, with a significant focus on medical devices or highly regulated industries.
• Proficiency in 3D CAD software (e.g., Solid Works, Inventor) and experience with PDM systems.
• Experience with simulation tools (FEA) for performance and reliability analysis.
• Strong understanding of material science, biocompatibility, sterilization methods, and precision manufacturing processes relevant to medical devices.
• Knowledge of regulatory requirements for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485).
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong communication and teamwork abilities, essential for a collaborative hybrid work environment.
• Familiarity with human factors engineering principles is a plus.

Our client offers a competitive salary and benefits package, including comprehensive health coverage, retirement savings options, and opportunities for professional development. The hybrid work model supports work-life balance, providing flexibility. Employees contribute to life-changing medical technologies, working in a stimulating and growth-oriented environment. Our client invests in their employees' career advancement through training programs and challenging projects within their Paarl facilities.

This is an opportunity to work with a dedicated team focused on improving patient outcomes through advanced engineering.