Manufacturing Engineer
3 weeks ago
(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.
- 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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