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Manufacturing Engineer II

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Engineering
📅
21000IHT Requisition #

Manufacturing Engineer II

Careers that Change Lives

Be a part of the Medtronic Engineering and Innovation center (MEIC) by applying your skills to the growth and development of Medtronic Neuroscience group team within MEIC.

As a member of MEIC Neuroscience 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.

A Day in the Life

 

  • Be part of an extended concurrent engineering team and provide support on Design transfers.
  • Support in the execution of transfer and readiness for transfer by partnering with facilities and suppliers for single point of contact support. 
  • Identify, evaluate and communicate supplier and facility readiness to accept the manufacturing of the product to be transferred.
  • Communicate project status and information to Operations leaders and stakeholders.
  • 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.
  • Maintains awareness and knowledge of continuous improvement efforts within Operations to incorporate these into programs in early phases e.g. MOS, Lean Doc, and Visual Management tools.
  • Contribute to achieving Core Team goals & objectives and actively participate in Core Team meetings.
  • Collaborate with 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, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.
  • Should maintain accountability and successfully deliver projects/tasks assigned.
  • Must learn and ensure compliance with all GBU design control processes and procedures.

 

Minimum Qualifications

  • Bachelor’s Degree in Mechanical/ Production Engineering or equivalent with 5 to 8 years of experience in manfacturing and operations.
  • Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
  • 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.
  • 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.
  • Able to effectively work with cross functional teams in a multinational matrix organization.
  • Superior written and verbal communication skills required.
  • Good attitude and team player.

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 people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

 

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