| Manufacturing Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Khayal Abbas, Scalable- Systems [email protected] Reply to: [email protected] Job Title Manufacturing Engineer 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 Experience Required 5+ years of experience & demonstrated proficiency in Manufacturing -Facility validation including developing and Implementing Validation Plans, IQ/OQ/PQ protocols, conducting risk assessments, and preparing validation reports preferably in the pharmaceutical or medical device industry. Work Location (State, City and Zip) Utah, Salt Lake City Keywords: |
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| Tue Dec 26 23:26:00 UTC 2023 |