Manufacturing Engineer Job at SysMind Tech in Salt Lake City

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