What are the responsibilities and job description for the Manufacturing Engineer position at Katalyst CRO?
Roles & Responsibilities
- Bachelor's degree in mechanical engineering, or related discipline or equivalent.
- Experience in drafting protocols & report generation (including Data Analysis) .
- Knowledge in Test method development & Validation.
- Experience to use of statistical software's (ex: Minitab, JMP), six sigma training and/or certification.
- Experience in SolidWorks (or similar CAD software), MS project, basic understanding of FDA, Good Manufacturing Practice "GMP and ISO guidelines.
- Familiar with the use of various inspections tools (Ex: pin gauge, caliper, micrometer, snap gauge, drop gauge, block gauge, optical comparator, vision system, etc.) .
- Experience working in a medical device manufacturing environment (Ex: extrusion, injection molding, laser cutting, cleaning, passivation, electropolishing, assembly, bonding, packaging, testing, inspection methods etc.,) .
- Basic understanding on GD&T, tolerance stack up analysis, Statistical Process Control "SPC, fundamentals of Design of Experiments "DOE and problem-solving methodologies .
- Good experience in cross functional interactions & Good experience in technical writing skills .
- Good communication skills .
