Mechanical Design Engineer - Medical Devices

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

About the Role

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.

Key Responsibilities

• 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.

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., SolidWorks, 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.

Benefits

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.