Biomedical Engineer

Join Our Research & Development Team

Are you passionate about innovation, medical technology, and solving real-world problems? We’re looking for a highly motivated and detail-oriented biomedical engineer to join our Research & Development department. In this role, you’ll be at the forefront of designing and developing cutting-edge medical devices — from initial concept through to production — in a dynamic, regulated environment.

You’ll work closely with a multidisciplinary team to turn technical requirements into practical, life-enhancing solutions. If you thrive in a high-performance setting, have strong analytical and problem-solving abilities, and are excited by the challenge of working on Class II and III medical devices, we’d love to hear from you.

Job Title

Biomedical Engineer

Department

Research & Development

Qualifications Required

Tertiary degree in biomedical engineering or related fields.

Knowledge, Skills and Experience Required

Strong engineering knowledge and skills
Highly analytical with exceptional attention to detail
Problem-solving ability
Excellent report-writing skills
Excellent communication skills
Ability to work in a highly regulated environment
Practical machining, tooling and workshop skills
Ability to process information quickly and react accordingly without supervision
Ability to convert technical requirements into practical equipment
Self-driven and able to work independently, but function well as part of a team
Quick learner and problem-solver
Ability to convert technical requirements into functional equipment and devices
Goal-focused
Experience with computer-aided design (preferably SolidWorks)
Strong knowledge of Excel as well as statistical methods of analysis
Strong knowledge of human anatomy, physiology, and medical device functionality.
Familiarity with design control processes under ISO 13485 and FDA 21 CFR Part 820
Experience with rapid prototyping, lab testing, and statistical analysis tools
Knowledge of materials used in medical devices, including biocompatibility considerations
Experience with Class II or III medical devices would be advantageous.
Understanding of sterilization methods (e.g., ETO, gamma, steam) and packaging validation methods.
Familiarity with risk management (ISO 14971), usability engineering (IEC 62366), and software lifecycle (IEC 62304)

Key Roles and Responsibilities

Design and development as part of R&D projects, including prototype manufacture
Design and develop new ideas of medical Devices from concept through production.
Conduct feasibility studies and performance testing of biomedical products
Collaborating with cross-functional teams including R&D, quality assurance, regulatory affairs, and manufacturing
Test method development and coordination of product testing
Prepare detailed engineering documentation including design specifications, test protocols, and validation reports.
Assist in the development of production processes and troubleshoot manufacturing issues
Compilation of reports and Technical Files/Design Dossiers for regulatory submission
Prepare detailed engineering documentation including design specifications, test protocols, and validation reports.
Risk Management activities
Perform data analysis from clinical or laboratory testing to improve product design
Maintenance and improvement of premises and equipment
Process and equipment validation activities
Procurement, calibration and maintenance of production equipment (IMTE system), as well as R&D equipment
Procurement of materials and fabrication of equipment according to detailed specifications
Training in all manufacturing processes
Assist Quality department with auditing processes, where necessary
Assisting Operations Manager in training production staff
Balloon developments and redevelopments
Contribution of technical input and problem solving to resolve customer complaints
Other ad hoc tasks, as required.