
Medical Device Electronics Specialist
2 days ago
Electronics Expertise Sought
We are seeking a highly skilled Electronics Engineer to lead our R&D team. The ideal candidate will have expertise in designing and developing electronic systems for medical devices.
Key Responsibilities:
- Design and develop electronic systems for medical devices, including architecture definition, requirements specification, prototype design, risk assessment, and manufacturing specification.
- Support the preparation of compliance packages for product certification, including IEC 60601-1 and IEC 60601-1-11.
- Coordinate test execution and create verification reports.
- Manage development projects to ensure that all commitments are achieved within aggressive timelines while meeting quality standards.
- Ensure full compliance with quality, regulatory, health, and safety procedures.
- Support design transfer to manufacturing and provide effective internal and external communications and reporting.
- Develop and lead R&D engineers and other technical staff.
Required Skills/Experience:
- Minimum Bachelor's Degree in Electronics/Electrical Engineering.
- 5+ years previous experience in a Medical Devices environment with knowledge of medical device product development, certification, and manufacturing processes.
- Knowledge of RF and radio-associated standards and certification processes is desirable.
- Highly competent in design of Analog and Digital Electronics.
- Experienced in use of tools for Electronics Design (schematics capture, PCB design, etc) – OrCAD platform preferred.
- Experienced in electronics testing/troubleshooting.
- Experience with Electronics manufacturing.
- Competent with 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 is desirable.
- Experience in EMC testing.
- Experience with firmware (C/C++ coding) is desirable.
- High-level computer skills, including Microsoft Excel, PowerPoint, and Word, and MS Project.
- Experience working in Agile manner with Jira, Confluence, or similar is desirable.
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