Manufacturing Engineer

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