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Product Engineer, Cleveland, OH

Primary Responsibilities

  • Provide electrical/software technical support to the engineering, operations and quality teams.
  • Generates and maintains schematics, production BOMs, inspection plans, and other product documents.
  • Implements electrical design improvements and modifications after product launch.
  • Works towards resolution of manufacturing and product issues (NCMR, complaint, and CAPA support).
  • 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.
  • 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.

Requirements

  • Bachelor’s Degree in Electrical Engineering, Software Engineering or related field.
  • Minimum of 2 years in an embedded electronics or software development industry.
  • Experience with microcontrollers and their interfacing with low-power analog circuits.
  • Familiarity with the C programming language.
  • Experience with FDA/GMP regulated medical device design and manufacturing preferred.
  • Understanding of medical device DHF, DMR, and DHR files management and documentation requirements preferred.
  • Problem solving and troubleshooting skills in products and sub-assemblies, manufacturing and test equipment.

Why Join Our Team?

  • Entrepreneurial work environment
  • Small, collaborative office environment.
  • Competitive compensation and benefits
  • Flexible work/life balance
  • Wellness Program
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