Manufacturing Engineer

3 weeks ago


Salt Lake City, United States SysMind Tech Full time
Relevant Experience

(In Yrs)

5+ years of experience & demonstrated proficiency in manufacturing, Process validation & providing ongoing technical support is preferred with evidence of continued self-development.
  • Work experience in the Medical Device industry.
Must Have Technical/Functional Skills
  • In-depth knowledge of FDA regulations, Industry standards, and guidelines such as ISO 13485 and ISO 14644.
  • Experience in control facility, warehouse and cleanroom validation
  • Knowledge of Medical Equipment manufacturing processes
  • Experience with IQ/OQ/PQ protocols
  • Experience with conducting Test method validations.
  • Ability to qualify Tooling, Gages and Fixtures
  • Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics
  • Knowledge of biocompatibility in medical device industry
  • Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)
  • Understanding of Process development & design and Quality Function Deployment
  • Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills.
  • Demonstrated understanding of Ergonomics and financial analysis skills preferred.
  • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred.
  • Understanding of Marketing & market research strategies
  • Personal computer skills, Windows: word processing, project planning,

presentation, e-mail, web browsers & spreadsheet software

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