Sr Manufacturing Engineer.
2 months ago
Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of CST Ops under Global manufacturing group team within MEIC.
As a member of GO & SC group you will collaborate closely with all the necessary stakeholders on the assigned tasks and projects including your counterparts in the US to ensure timely and successful completion of the same
PRIMARY RESPONSIBILITIES
Responsibilities may include the following and other duties may be assigned.
·Generating Design & Manufacturing Transfer Deliverables (Plans and Reports)
·Working with Stakeholders to set Manufacturing Process / Transfer & related deliverables
·Supporting to designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
·Support in the execution of transfer and readiness for transfer by partnering with facilities and suppliers for point of contact support.
·Identify and communicate Operations and Program risks. Drive risk mitigation activity as necessary.
·Prepare or review necessary validation plans, protocols and procedures for successful completion of transfer activities. (IQ,OQ,PQ,MVP/MVR, SPC control, GRR, etc..)
·Contribute to achieving Core Team goals & objectives and actively participate in Core Team meetings.
·Collaborate with Internal Mfg Sites & supplier(s) to design, characterize and qualify high capability processes producing consistent finished products.This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans.
·Should maintain accountability and successfully deliver projects/tasks assigned.
·Must learn and ensure compliance with all GBU design control processes and procedures.
·Knowledge about ISO13485, ISO14971.
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.
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