Mechanical Design and Development Engineer
4 weeks ago
Medtronic is a world leader in providing healthcare products that benefit individuals' well-being. Our organization contributes directly to this mission. Our business is growing significantly as the market demands reliable medical devices which look and feel more like consumer devices.
A Day in the Life
As a Mechanical Design Engineer II at Medtronic, you will ensure best quality and in-time delivery of the given assignments for our products. Key responsibilities include working with stakeholders to set manufacturing processes, supporting designs for manufacturing processes, procedures, and production layouts, identifying and communicating operations and program risks, and preparing or reviewing necessary validation plans and protocols.
Key Skills and Qualifications
• Bachelor's degree in Mechanical Engineering with 5 to 8 years of relevant experience.
• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
• Knowledge on GD&T & experience in interpreting mechanical drawings.
• Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation.
• Strong Knowledge in Lean Manufacturing/Six Sigma methodologies
• Thorough knowledge and effective application of Design for Manufacturability, Design for Inspectability, Validation Protocol and Report creation, SPC, Process Control Plans, MSA, Gauging applications, design, and construction, Sampling methodologies, Data Analysis
Nice to Have
• Medical device product development and/or manufacturing experience and a strong understanding of FDA, ICH, and IEC-standards.
• Experience across the entire product lifecycle.
• Experience working in a highly regulated industry (e.g. medical device, pharmaceutical, automotive).
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