Why join one start-up when you can join many? DxD is a Design and Development house that helps inventors through the productization process.
We are looking for an Electronics Engineer with a passion for simplifying sophisticated problems and driving projects toward clarity.
You will be working with various technical teams to develop and determine the product requirements during the total life cycle of the medical diagnostics devices: from the conception and development phase, through verification and validation, clinical validation, manufacturing and commercial launch, in designing and building electronics modules such as with optoelectronics functions, temperature and fluid control, data management and device communication, amongst others. These modules or specific functions would be required for the process flow of bio-assays for medical diagnostics devices ranging from small hand-held, to large complex medical devices.
Your role would also be to liaise with vendors and system integrators at the technical level to integrate the desired solution into the product and ensure the integrated medical diagnostics products fulfils its intended purpose within performance specifications, and small scale manufactured products would retain all the required functions for medical diagnostics, as well as meet safety requirements associated to its use and expected misuse, as described in ISO13485 guidelines for medical devices. You will also participate and contribute to risk evaluation of your proposed solution to the product according to ISO14971 for Risk Management.
This would also include establishing and ensuring the suitability of third-party off-the-shelf components, as well as modules supplied by collaborators and/or suppliers of collaborators, to ensure the safety of the medical diagnostics device during the total product life cycle.
You will be involved in projects in collaboration with external partners, collaborators and co-developers. There you will also be involved in understanding the collaborators’ systems, identify the products' requirements, and identify the optimum electronics solutions, e.g. for the next generation products.
At least 3 years experience in Electronics Engineering or related fields.
Good understanding and appreciation of electronics components, modules and systems: ability to select and implement electronics solutions in a module and work with a team to integrate the solution into a device. For example:
Experience with quality management system based on ISO13485 and ISO14385 for medical devices would be preferred.