- 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
Required Qualifications- Bachelor's degree in Mechanical Engineering, or related discipline or equivalent
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