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Electrical Engineer – Cleveland, OH
- Performs electrical engineering tasks and provides technical support to the operations and quality teams.
- With appropriate guidance, monitors and advises engineering team of design issues, concerns and required changes, researches suitable solutions and estimates cost and timeframe for completion.
- Contributes to the development of devices through direct design and development as well as through participation in development teams or other projects.
- Plans and Executes the testing of prototypes, pre-production, or finished products to verify design requirements are met, to establish criteria or limits for product specifications consistent with the intended use of the product, or to assure established specifications are consistently met or exceeded by in-process and finished product manufacturing and test processes.
- Operates within the design controls and other standard operating procedures that assure product development and production activities comply with FDA, ISO 13485, and other regulatory requirements.
- Interacts with vendors and suppliers to select/approve electrical components/subassemblies that comply with device requirements and specifications.
- Works towards resolution of manufacturing and product issues (NCMR, complaint, and CAPA support).
- Other related duties as assigned.
- Bachelor’s Degree in Electrical Engineering or related field.
- Minimum of 4 years in an electronics industry.
- Minimum 1-4 years of experience with FDA/GMP regulated medical device design and manufacturing.
- Project management including planning, execution, and meeting time and budget constraints.
- Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
- Problem solving and troubleshooting skills in products and sub-assemblies, manufacturing and test equipment.
- Experience with microcontrollers and their interfacing with low-power analog circuits.
- Basic familiarity with the C programming language.
- Ability to travel periodically and typically with advanced notice.
Why Join Our Team?
- Entrepreneurial work environment
- Small, collaborative office environment.
- Competitive compensation and benefits
- Flexible work/life balance