Process Development Engineer II - Plymouth, MN

Process Development Engineer II

Careers that Change Lives

At Medtronic, we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. 

The Process Development Engineer II will lead the development of manufacturing processes for new products for the Peripheral Vascular Health (PVH) business. This position will work with other functions within the program team; but will have ownership for plans, reports, data collection, or other means necessary to gain the knowledge required to create and document the associated manufacturing procedures. You will also collaborate with design colleagues to ensure designs are capable of meeting performance and manufacturing targets. This position will support in data collection and review of regulatory submission-ready documentation for the FDA and other regulatory bodies. 

The PVH operating unit offers a diverse portfolio of devices and therapies to treat restore the right blood flow to the right patient.

Peripheral Vascular Health therapies treat patients with Peripheral and Carotid Artery Disease, End-Stage Renal Disease, Superficial and Deep Venous Diseases, and a variety of conditions treated with Peripheral Embolization. The operating unit leads the way in the Superficial Venous, Deep Venous Stenting, and Drug-Coated Balloon markets, caring for nearly 1 million patients globally with lifesaving and life-enhancing therapies.

This position is in Plymouth, MN. within the Peripheral Vascular Health (PVH) operating unit and requires on-site presence.

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.

A Day in the Life 

In general, the following responsibilities apply for the Process Development Engineer II.  This includes, but is not limited to the following:

·       Support 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.

·       Pilot Line Development: Design manufacturing sequence of operations/workflow and specifications for equipment/tooling to ensure most efficient and productive layout.

·       Feasibility Studies: Perform feasibility studies that explore new process technologies and evaluate its potential for application to catheter manufacturing. Analyze results and make recommendations.

·       Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations. Design and develop equipment and fixture requirements and its process parameters where applicable. Work with suppliers and internal stakeholders to realize design and ensure it meets specified requirements.

·       Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Develop plans to evaluate process capability. Perform test method development and validation. Apply six sigma methodologies as appropriate.

·       Defines and generates all required documentation in support of manufacturing products and processes.  These includes designing and writing engineering protocols in compliance with GMPs and internal procedures, FMECAs, reports, manufacturing instructions and procedures.  Use of appropriate six sigma methodologies such as Design of Experiments (DOEs), Gage R&R, and other statistical tools as necessary.  Provides in depth analysis of issues or problems and implements process improvements to enhance performance of the job area.

·       Collaborates with product development teams to support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.  Communicates with senior internal groups and frequent interaction with external groups (i.e. vendors, suppliers, etc.).

·       Develops cost benefit analyses and implements process improvements initiatives to reduce and/or optimize product costs.

·       Domestic and international travel anticipated up to 10%.