Pretoria/Centurion – Gauteng
A Health Tech Solution Company located in Pretoria is currently in search of an Electronic Engineer to contribute to the enhancement of existing audiometric devices and the development of new products within their B2B division. This role entails working on both the hardware and software components of medical devices, as well as the documentation and ensuring compliance with various product-specific and regulatory standards and directives related to audiometric products. Successful candidates will be expected to collaborate on projects at different stages of development with various internal teams, maintain effective communication with scientific advisors, subject matter experts, and external manufacturers or suppliers of goods and services. The successful candidate will have 1 – 3 years’ applicable experience and a minimum essential BEng in Electronic Engineering.
Electronic Engineering 30%
- Design and development of components for audiometric products.
- Manage medical device design and development requirements.
- Assist with risk assessments, clinical investigations, and product regulatory research.
- Lead hardware developments on hearOAE, including product fixes, new features, and improvements.
- Lead clinical evaluation efforts for new medical devices.
- Provide input for clinical and technical evaluation of hearTest and hearScope.
- Upkeep and improve current product on an ongoing basis.
- Conduct EMC testing as and when required.
- Ensure the current products and new products adheres to device specific and EMC standards.
Research & Development 50%
- Conduct research on new product development (50%)
- Conduct research on product improvement (16.6%)
- Develop prototype hardware as required, including arranging manufacturing quotes and services (16.6%)
- Troubleshoot and test mobile device hardware issues relating to the company’s software (16.6%)
Product Compliance 10%
- Provide technical input and expertise for all relevant medical device regulations.
- Research new regulatory requirements and compliance related topics
- Provide guidance and advice to product development team for implementation strategies and solutions for regulatory compliance.
- Assist with medical device qualification and certification.
Product Operations 10%
Oversee specifics of product manufacturing processes including calibrations
Assist with manufacturing operations of device setup and calibration as and when required.
Assist with validation of new stock (headphones and smartphones)
Control and monitor audiometric measuring equipment, including scheduled maintenance and calibrations.
- Calibration processes
- Medical devices
- PCB design software like Altium or other free EDA software.
- Digital signal processing techniques as it relates to audio, and biomedical signal processing techniques. Software expertise in Matlab or alternatives are required.
- Low noise, low distortion analogue circuit design.
- Design mechanical parts for electronic hardware or transducers (e.g., probes). Requires experience with CAD software like Solidworks.
- Possess knowledge of acoustics as it relates to accurate measurement and quality assurance.
- Perform technical compliance testing including Basic safety testing (60601-1), EMC (60601-1-2), and product-specific standards (e.g., Audiometer standards – EN/IEC 60645-1).
- Support the legal and regulatory (L&R) team by providing the necessary information for medical product registration concerning CE and FDA.
- Prepare documentation required for the Quality Management System (QMS)
- Assist with or document manufacturing processes.
- Assist B2C division as required.