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Engineering
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19000D47 Requisition #
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POSITION DESCRIPTION:  

Develop and improve complaint handling methods, systems, and processes at an optimal cost for MITG Post Market Vigilance (PMV).  Responsible for all overall process flow to ensure quality, operational cost and timeliness within PMV complaint handling labs and operation sites.  Act under general supervision of Manager of PMV Quality Services on multiple assignments of complex scope.  

The primary focus of this role utilizing the MOS/COS system, will aid the tool/system development, project execution, and to drive value through PMV process improvements and optimizations.  

Position Locations: North Haven, CT. Boulder, CO. Mounds View, MN. 

POSITION RESPONSIBILITIES:

• Position will be responsible to coordinate the activities within MITG PMV to implement cell methodology and COS/MOS within the PMV function. 
• Continuous Improvement and Cost Analysis:  Continually improves MITG PMV methods and systems using Lean Enterprise philosophies and DMAIC methodologies to optimize process performance and reduce costs.  Identify and evaluate opportunities for improvement inherent in processes and make specific recommendations for adoption; perform detailed cost analysis 
• Day to Day Support and Trouble Shooting:  Provides process engineering support to MITG PMV on a routine basis.  Addresses process related issues using DMAIC A3 problem solving. Works to standardize processes and problem solving.
• Develop and Optimize Work Design and Process Flow:  Recommends and implements process using lean philosophies for increased efficiency in complaint handling.  Collaborate cross functionally and develop tools to provide appropriate staffing level to support MITG PMV requirements (Capacity planning).
• Project Leadership:  May lead teams in MITG PMV related programs including CAPAs, cost reductions, and process changes across MITG sub business units.  
• Drive execution by partnering with cross-functional and international business partners.
• Train MITG PMV staff to standardize DMAIC A3 problem solving and other processes and methodologies as necessary.
• Aid in the execution of organization and process changes across MITG PMV.

A Day in the Life

 

Responsibilities may include the following and other duties may be assigned.

  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.
Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have

EXPERIENCE
• experience managing projects and/or professional level staff

SPECIALIZED KNOWLEDGE:
• Experience with root cause analysis, Lean Sigma, and/or DMAIC methodologies for driving process improvements.  
• Black Belt or Green Belt Preferred
• MOS/COS experience in the manufacturing environment preferred
• Project Management Experience
• Process Oriented 
 
QUALIFICATIONS:
•Exposure to Continuous Improvement Philosophies (Medtronic Operating System, Lean Transformation, Six Sigma, Visual Management)
•Demonstrated ability to lead others to drive process excellence and compliance
•Strong communication and influencing skills
•Lean Sigma Certified, Green belt or Blackbelt
•Demonstrated analytical and oral/written communication skills, including ability to use independent judgment in decision-making 
•Demonstrated ability to function independently and effectively in a fast-paced, high volume environment
•Experience starting and leading multiple projects to completion 
•Experience effectively operating cross-functionally with key stakeholders - The key stakeholders could include MITG PMV site leaders, pre/post market quality, regulatory, legal, clinical, released products, operations and R&D, marketing, sales, international partners and others.
•Ability to translate broad strategies into specific objectives, metrics and action plans
•Proven influence management skills
•Proven ability to successfully execute under aggressive timelines
•Hands on experience in process development. 
•Experience in engineering, manufacturing engineering operations
•Process improvement, auditing, data analysis or project management certification
•Working knowledge of CAPA, GCH, and document-controlled databases 

Travel requirement: approx. 25%

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.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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