Biomedical Engineer

Career 2000 Medical Recruitment; Gauteng; On-site; ZAR 400 000 - 600 000; Full time

Job summary

A leading medical recruitment agency is seeking a Biomedical Engineer in Gauteng. The role involves designing and developing medical devices, ensuring compliance with regulatory standards, and collaborating with various teams. Ideal candidates will have a degree in Biomedical Engineering and experience with medical devices.

Qualifications

• Tertiary degree in Biomedical Engineering is essential.
• Experience with Class II or III Medical Devices is advantageous.
• Familiarity with ISO and FDA standards is ideal.

Responsibilities

• Design medical devices from concept to production.
• Test biomedical products and compile reports.
• Create design dossiers for regulatory submissions.

Skills

Design

Testing

Regulatory Compliance

Statistical Analysis

Prototyping

Collaboration

Education

Tertiary degree in Biomedical Engineering

Tools

SolidWorks

Job description

Biomedical Engineer

CAREER MEDICAL RECRUITMENT, Northriding, Gauteng, South Africa

Position: Biomedical Engineer

Location: Northriding, Gauteng, South Africa

Job Description

We are seeking a Biomedical Engineer with experience in Class II or III Medical Devices. The role involves collaboration with R&D, QA, RA, and Manufacturing teams to design and develop medical devices from concept to production, ensuring compliance with regulatory standards.

Key Responsibilities

1. Design medical devices from concept through to production.
2. Test biomedical products and compile reports and technical files.
3. Create design dossiers for regulatory submissions.
4. Procure, calibrate, and maintain production and R&D equipment, including IMTE systems.

Qualifications & Experience

• Tertiary degree in Biomedical Engineering (essential).
• Experience with Class II or III Medical Devices (advantageous).
• Work experience aligned with duties 1-6 below (mandatory).
• Experience with SolidWorks (ideal).
• Familiarity with design processes under ISO and FDA 21 CFR Part.
• Experience with rapid prototyping, lab testing, and statistical analysis tools.
• Knowledge of materials used in medical devices and biocompatibility considerations.
• Familiarity with ISO Risk Management, IEC Usability Engineering, and Software Lifecycle standards.

Additional Responsibilities

• Procurement, calibration, and maintenance of production equipment, including R&D tools.

Employment Details

Seniority Level: Entry level

Employment Type: Full-time

Job Function: Research, Analysis, and Information Technology