Sr Manufacturing Engineer

Must Have: Minimum Requirements

·       Bachelor’s Degree in Mechanical/ Production Engineering or equivalent with 8 to 10 years of experience in manufacturing and operations.

·       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

·       High degree of understanding/knowledge of Machining, Molding, Grinding, Forming, Assembly, Welding, Finishing, Cleaning, Passivating, Anodizing, Shot Peening, Mass Media Operations, Coatings, EDM, Casting, Forging, Polishing

·       Good understanding on inspection methods and procedures. (Test Method validation TMV)

·       Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools.

·       Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred.

·       Knowledge on Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. (Any PLM)

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)

·       Experience with problem solving methodologies, manufacturing process validation

·       Project engineering or program management experience in a new product development and/or manufacturing environment

·       Demonstrate strong problem-solving skills and the ability to ask critical questions without being the subject matter expert

·       Ensure structured problem methods and predictive engineering principles are consistently and rigorously applied, such as Design for Six Sigma, Lean Manufacturing, DFMA, DRM, FTQ or similar concepts.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of  what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right