Electronics Systems Engineer
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Our high potential medical device start-up is seeking a skilled Electronics Systems Engineer to join their team. Reporting to the Electronics Engineering Director, this professional will provide technical leadership across all stages of development for electronic systems in medical devices, including design, testing, manufacturing, documentation, etc.
Key Responsibilities:
* Design and develop electronics systems for medical devices, including architecture definition, requirements specification, prototype design, risk assessment, and manufacturing specification.
* Manage external contractors / suppliers and prepare compliance packages for product certification, including IEC 60601-1 and IEC 60601-1-11 (Basic Safety and Essential Performance) and IEC 60601-1-2 (Electromagnetic compatibility).
* Coordinate test execution and create verification plans, protocols, and test methods.
* Ensure full compliance with quality, regulatory, health, and safety procedures.
* Support design transfer to manufacturing and provide effective internal and external communications.
* Train and develop R&D engineers and other technical staff.
Requirements:
* Bachelor's degree in Electronics or Electrical Engineering.
* 5+ years experience in medical devices environment with knowledge of product development, certification, and manufacturing processes.
* Experience with RF technologies and associated standards and certification processes.
* Competent in analog and digital electronics design and PCB design using OrCAD platform.
* Knowledge of IEC 60601-1 standard series, including IEC 60601-1-2 (EMC) and IEC 60601-1-11 (Home use devices).
Benefits:
* Opportunity to work on cutting-edge medical device projects.
* Collaborative and dynamic work environment.
* Chance to develop skills and expertise in electronics engineering.
Others:
* High level computer skills including Microsoft Excel, PowerPoint, and Word.
* Experience working in Agile manner with Jira, Confluence, or similar desirable.