Senior Process Development Engineer - Plymouth, MN

Senior Process Development EngineerCareers that Change LivesAt 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 Senior Process Development Engineer 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.This position is in Plymouth, MN. within the Peripheral Vascular Health (PVH) operating unit and requires on-site presence.A Day in the LifeIn general, the following responsibilities apply for the

Senior Process Development Engineer . 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 the 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 include 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 improvement initiatives to reduce and/or optimize product costs.Domestic and international travel anticipated up to 10%.MUST HAVE - MINIMUM REQUIREMENTS:TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUMEBachelor’s degree in Engineering, or a technical disciplineMinimum of 4 years of work experience in Engineering, OR Advanced degree in Engineering, or technical discipline with 2 years of work experienceNice to HaveExperience in medical device manufacturing or manufacturing in highly regulated industry/environmentPrior knowledge and experience in new product developmentWorking knowledge of statistical tools such as DOE, SPC, Hypothesis Testing and Process Capability StudiesExperience with polymer extrusion, thermal bonding, adhesive bonding or laser processingSix Sigma training and/or certificationAbout MedtronicTogether, 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.This position is eligible for a short-term incentive plan.The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.Base pay is based on numerous factors and may vary depending on job-related knowledge, skills, and experience.Additional Information:Posting Date: May 22, 2024Travel: Yes,

Salary Min: 100,800Salary Max: 151,200

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