What are the responsibilities and job description for the Design Engineer for Medical Devices position at Electromed, Inc.?
About the Opportunity:
The Senior Mechanical Design Engineer will play a key role in the development of electromechanical medical devices. This position reports directly to the Director of Engineering and is based in New Prague, MN.
Key Responsibilities:
- Provide support for continuation engineering issues.
- Coordinate communication between R&D and other cross-functional teams.
- Determine change impact on mechanical/electromechanical design and document rationales.
- Develop automated test stations.
- Maintain bill of materials using product lifecycle management process.
- Generate solutions that are imaginative, thorough, practical, and consistent with organizational objectives.
- Prepare documentation in accordance with relevant internal procedures and design control.
Requirements:
- Masters of Science Degree in Mechanical Engineering or Bachelors of Science Degree in Mechanical Engineering plus two years relevant experience.
- Experience in the medical device industry preferred.
- Exposure to IEC 60601-1, ISO 13485, and 21 CFR part 820.
- Knowledge of electromechanical systems.
- Clinical knowledge for uses of product.
- Understanding of design verification and validation.