Electrical Engineer
1 week ago
We are seeking a highly skilled Electrical Engineer to join our team in designing and developing cutting-edge medical devices. As an Electrical Engineer, you will play a crucial role in all aspects of medical device development, including concept generation, design, prototyping, and manufacturing transfer.
You will have the opportunity to integrate systems engineering principles into the development process, ensuring that all components work harmoniously to meet regulatory and clinical requirements. This position offers a unique chance to collaborate with government bodies to obtain regulatory approval and work with the IP department to issue patents, contributing to innovative solutions in the medical device sector.
Your Responsibilities Will Include:- Designing medical devices through prototyping, testing, and modeling, with a focus on systems integration and performance optimization.
- Participating on project teams to translate user needs into design requirements.
- Developing validation plans and conducting validation testing to ensure that all systems meet stringent safety and efficacy standards.
- Developing and testing new manufacturing processes, ensuring they align with both engineering specifications and regulatory guidelines.
- Supporting regulatory filings to various government bodies, ensuring compliance with applicable standards and regulations.
- Contributing to the development of intellectual property by identifying and protecting novel design solutions and engineering processes.
- Supporting pre-clinical and clinical research activities, ensuring that system-level performance is validated in real-world scenarios.
- Bachelor's degree in electrical engineering, systems engineering, or a related field.
- 2+ years of experience with product development activities in a regulated industry, specifically in the medical device sector.
- Knowledge of design requirements as per ISO 13485 and other relevant regulatory standards.
- Extensive experience with IEC 60601-1 and IEC 60601-1-2 standards and test procedures.
- Hands-on experience in designing and setting up electrical testing and equipment.
- Extensive design experience in electrical schematics/layouts, system grounding, and digital/analog architecture.
- Experience leading rapid design iterations and making informed design recommendations based on systems-level analysis.
- Strong hypothesis-driven experimental design and statistical analysis skills to assess system performance.
- Experience with power circuit design, power semiconductors, and magnetic components, emphasizing systems performance.
- Familiarity with analog and low-speed digital circuit design within the context of integrated medical systems.
Estimated Salary: $120,000 - $180,000 per year
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