Mechanical Design Engineer (New Product Development)

Placements24; Soweto; On-site; ZAR 420,000 - 720,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Professional development

Career stability

Job summary

Placements24 is seeking a Mechanical Design Engineer for its client in Soweto, Gauteng. The role focuses on developing new medical devices from concept through prototyping to manufacturing, with emphasis on regulatory compliance and design history files.

The ideal candidate will bring 3+ years of mechanical design experience, proficiency in SolidWorks or Inventor, and a strong grasp of materials and regulatory requirements for medical devices. This is an on-site role in Soweto.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 3+ years in mechanical design, preferably medical devices.
• Proficiency in CAD software (SolidWorks, Inventor) with basic CAE understanding.
• Knowledge of materials used in medical devices.
• Familiarity with FDA/ISO 13485 design controls.
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork.
• Detail-oriented with commitment to quality and precision.

Responsibilities

• Design and develop mechanical components for new medical devices using CAD.
• Create detailed drawings, specifications, and BOMs.
• Perform stress, strain, and tolerance analyses to ensure design integrity.
• Collaborate with R&D, regulatory affairs, QA, and manufacturing.
• Develop prototypes and support testing/validation activities.
• Ensure designs comply with medical device regulations (ISO 13485).
• Troubleshoot design challenges and implement solutions.
• Assist in transfer of designs to manufacturing and ramp-up.

Skills

Analytical skills

Problem-solving

Communication

Teamwork

Detail-oriented

Quality focus

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Inventor

CAE tools

Job description

About the Role

Our client, a dynamic innovator in the medical device industry, is actively seeking a talented Mechanical Design Engineer to join their dedicated New Product Development team in Soweto, Gauteng . This on-site role is integral to the design and development of cutting-edge medical devices, requiring meticulous attention to detail and a strong grasp of mechanical engineering principles. You will be involved in the entire product development process, from initial concept and design to prototyping, testing, and preparing for manufacturing. This is an exciting opportunity to contribute to life-saving technologies and work within a highly regulated and quality-focused environment. We are looking for a passionate and driven engineer eager to make a tangible impact on healthcare through innovative design solutions.

Key Responsibilities

• Design and develop mechanical components and sub-assemblies for new medical devices using CAD software.
• Create detailed technical drawings, specifications, and Bills of Materials (BOMs).
• Perform engineering analysis, including stress, strain, and tolerance analysis, to ensure design integrity.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, quality assurance, and manufacturing.
• Develop prototypes and support product testing and validation activities.
• Ensure designs comply with medical device regulations (e.g., ISO 13485) and industry standards.
• Troubleshoot design challenges and implement effective solutions.
• Contribute to the documentation required for regulatory submissions and design history files.
• Assist in the transfer of designs to manufacturing, ensuring smooth production ramp-up.
• Research and evaluate new materials and technologies for potential application in medical devices.

Requirements

• Bachelor’s degree in Mechanical Engineering or a related field.
• Minimum of 3 years of experience in mechanical design, preferably within the medical device or related regulated industry.
• Proficiency in CAD software (e.g., SolidWorks, Inventor) and a basic understanding of CAE tools.
• Knowledge of materials commonly used in medical devices and their properties.
• Familiarity with medical device design controls and regulatory requirements (e.g., FDA, ISO 13485).
• Strong analytical and problem-solving skills.
• Excellent communication and teamwork abilities.
• Must be able to work full-time at our facility in Soweto, Gauteng .
• Detail-oriented with a commitment to quality and precision.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health insurance and retirement planning.
• This role provides the chance to work on impactful medical devices that improve patient outcomes.
• Employees benefit from professional development opportunities, a supportive team environment, and the satisfaction of contributing to advancements in healthcare technology.
• Located in Soweto , this position offers a stable and rewarding career path within a growing and innovative company.
• Join us and be part of a team dedicated to engineering excellence in the medical field.