Electronics System Developer
* Develop electronic systems for medical devices including architecture definition, requirements specification, prototype design and risk assessment.
* Manage relationships with external contractors or suppliers.
* Support the development of compliance packages for product certification including IEC 60601-1 and IEC 60601-1-11 standards.
* Create verification plans, protocols and test methods to ensure product reliability.
* Coordinate project timelines to meet commitments while maintaining budgetary constraints.
* Ensure adherence to quality, regulatory, health and safety procedures.
* Support the transfer of design specifications to manufacturing.
* Provide effective internal and external communication and reporting.
* Lead the training, development and mentoring of R&D engineers and technical staff.
Job Requirements
* Bachelor's Degree in Electronics/Electrical Engineering.
* Minimum 5 years experience in a Medical Devices environment preferably with knowledge of medical device product development and certification processes.
* Knowledge of RF technologies and associated standards desirable.
* Proficient in electronics design using tools such as schematics capture, PCB design, OrCAD platform preferred.
* Experienced in electronics testing and troubleshooting.
* Understanding of electronics manufacturing and process control.
* Competent in RF technologies.
* Knowledge of IEC 60601-1 standard series including IEC 60601-1-2 (EMC) and IEC 60601-1-11 (Home use devices).
* Working knowledge of IEC 62304 desirable.
* Experience in EMC testing and compliance.
* Proficiency in firmware development (C/C++ coding) desirable.
* Strong computer skills including Microsoft Office applications and MS Project.
* Experience working in Agile environments using Jira, Confluence or similar software desirable.