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Class 1 medical device manufacturing consultant

Ab Manufacturing

This is a Full-time position in Minneapolis, MN posted May 28, 2019.

The Manufacturing Consultant is responsible for expanding Wilson Wolf’s manufacturing capabilities and more thoroughly systematizing associated processes to ensure that Wilson Wolf’s does not present a supply chain risk to large pharmaceutical companies that are purchasing its patented products.

Wilson Wolf’s are used to form to backbone of its customers T cell therapy manufacturing programs and supply safety is essential.

This position requires extensive experience that comes from having done hands on work in taking products and processes from a raw state to the next level of professionalism.

It isn’t a job for those that have only had the luxury of managing a large team, unless that was the result of having moves up the ranks and learned a great deal about medical device manufacturing, quality assurance and control, and also experienced a wide variety of mistakes along the way.

center around getting Wilson Wolf ready for prime time and avoiding mistakes as it scales it manufacturing capacity, while simultaneously working closely with the Company on a myriad of other activities including: Providing critical input into Company objectives Oversight of manufacturing engineering, purchasing, production supervisor, facility manager Ensuring that production output meets plan Maintaining a high level of efficiency in day-to-day aspects of manufacturing operations Transitioning new products into manufacturing Creating and implementing formal operational processes, procedures, and ongoing improvements Developing and implementing strategies to scale operations for growth and efficiency Overseeing manufacturing engineering, purchasing, production, facility personnel Evaluating operational performance regularly according to company goals and objectives Evaluating, monitoring, and reporting overall performance through key performance indicators Effectively building and motivating staff from multiple departments Overseeing and assisting personnel that are responsible for facility maintenance and improvements Establishing and maintaining efficient process for purchasing, inventory control and shipping and receiving functions Responsible for the development, maintenance and simulation of a Business Continuity Plan for the Wilson Wolf Manufacturing Operations Organization Work with component and finished device suppliers to evaluate their Business Continuity Plans : A proven track record that entails extensive experience and knowledge that can only come from a long history of doing things yourself and a history of learning from all the mistakes made along the way.

A proven track record of taking manufacturing to an elevated state of output and efficiency.

B.S.

in Mechanical Engineering or a related field 10+ years of manufacturing operations experience in an FDA regulated environment An energetic and collegial professional demeanor and a capability of identifying issues and working collaboratively to propose and implement practical solutions Ability to clearly and effectively communicate with all levels of staff within the organization, as well as customers and vendors Enjoys a variety of work in a fast-paced, high growth environment Self-motivated with ability to handle, organize and prioritize multiple tasks Thorough and detail oriented without losing the ability to see the big picture Experience in Quality Control and Quality Assurance Direct experience in manufacturing tool and equipment development Direct experience in product development Helpful : A strong network of other consultants that can be relied upon if need be Familiarity with Traction’s Entrepreneurial Operating System Experience with SolidWorks Experience with ERP selection and use A strong network of vendors related to disposable plastic medical devices Previous oversight of outsourced Contract Manufacturing Organizationsto applicants that are within driving distance from the Twin Cities by Jobble