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Process Engineer - Senior

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Engineering
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21000OEG Requisition #

Careers That Change Lives
Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide. 
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.
Join us to make a lasting impact. We believe that when people from different cultures, genders, and points of view come together, innovation is the result,and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
Help bring the next generation of life-changing medical technology to patients worldwide.

Medtronic Structural Heart in Santa Ana, California provides interventional devices to treat structural defects of the heart.  Be a part of a dynamic team that designs, develops and improves manufacturing methods, systems and processes to produce a high-quality product.  

This Senior Process Development Engineer will work on advanced manufacturing and development of  manufacturing processes for bioprosthetic heart valve implants during product development phases. The candidate will be well versed at process development, setting up manufacturing operations, and interfacing cross-functionally to develop and commercialize a product.

A Day in the Life
You will be a leading contributor in new product development activities, with specific responsibility for developing robust and capable manufacturing processes.  You will provide guidance, coaching and training to other employees within the team. As a seasoned individual contributor, you will provide solutions to complex technical problems using robust problem-solving techniques and project management methodologies. You will be involved in process innovation with emphasis on improving quality, reducing process variation, reducing cycle time and cost down initiatives.   
  
You will participate on cross-functional development teams that manage projects from concept through commercialization and will have a central technical role within the project team that considers requirements from R&D and Operations.  Be a part of a dynamic team who are driven to revolutionize the way we manufacture heart valves. 

Responsibilities may include, but are not limited to, the following:

•Process Technologies: Lead the exploration, feasibility evaluation, and development of new process technologies that can ultimately be incorporated into new product development projects or existing manufacturing lines. 
•Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields. Such activities include, but are not limited to, the following:
•Manufacturing Studies: Lead the strategy, development, and execution of manufacturing studies/ DOEs to characterize and drive development of robust, critical process specifications 
•Pilot Line Development: Lead and facilitate the design of manufacturing workflow to ensure most efficient and productive layout and ensure high quality outcome. Lead efforts and strategy for equipment and fixture development. 
•Process Transfer: Lead activities that are required for the transfer of pilot line to commercial operations. Such activities include, but are not limited to, the following:
•Transfer:  Lead pilot line transfer, process transfer, and/or process technology into commercial production or receiving site. Provide production support and troubleshooting as needed. Lead equipment and process qualification to support new product introduction. 
•Continuous Improvement and Cost Analysis:  Identify improvement opportunities in manufacturing method to optimize product output, quality and reduce manufacturing costs.  Lead/propose implementation strategy, benefit-cost analyses, and risk identification to support business case for adoption of improvement efforts. 

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:
•Bachelor of Science Degree in a Related Engineering Discipline (i.e., Mechanical, Biomedical, Industrial, Materials Science) 
•5+ years relevant experience or 2+ years relevant experience with relevant advanced degree
•Excellent oral and written communication skills, including presentation skills
•Solid interpersonal skills and ability to work in a cross-functional team environment
•Demonstrated experience with mechanical design including use of SOLIDWORKS or other computer modeling software
•Solid understanding of statistical techniques and analysis
•Demonstrated experience in new product development and the transfer of new products and/or process technologies into manufacturing
•Previous experience working in a clean room environment 
•Experience in project management and use of project management tools
•Familiarity with DMAIC/A3 problem solving approach
•Solid understanding of financial analysis
•Experience with equipment/tooling development with external suppliers
•Ability to identify and resolve issues without direct supervision

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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