180 Garsfontein Road, Ashlea Gardens, Pretoria
Remote Working
2 days work-from-home in line with Company Policy (only applicable after probation is successfully passed)
Job Purpose
Contribute to the development of new products and the improvement of current audiometric devices within the B2B division. This is achieved by working on both the hardware and software aspects of medical devices, documenting and ensuring the audiometric products comply with various product-specific and regulatory standards and directives.
The role requires the ability to work on projects in different phases of development alongside various internal teams. Effective communication with scientific advisors and SME's and external manufacturers or suppliers of goods and services is also essential.
Minimum Education (essential)
BEng Electronic Engineering
Minimum Education (desirable)
BEng Hons Electronic Engineering
Minimum Applicable Experience (years)
1-3 years
Required Nature Of Experience
Research, design and prototype of electronic hardware and software, both from a planning and hands-on perspective.
Troubleshoot and problem-solve electronic software and hardware systems.
Skills And Knowledge (essential)
- Firmware
- Software
- Hardware
- EMC
- 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 analog 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
- 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 including hearOAE.
- 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.
- 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 hearX software (16.6%)
- 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
- 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
