Donaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make meaningful contributions at work and in communities. Donaldson Company Inc's Medical Device group is looking for a Sr Engineer - Applications who will lead with technical expertise to drive new Medical Device product concepts into validated, commercialized product. This role offers the opportunity to contribute in a very high-visibility, high-impact area of our business as Donaldson is actively growing in their Medical Device and Life Science business units. We are looking for a self-directed and energetic candidate interested in pioneering application development that will lead to new material development and product development for the Medical Device market. The engineering leader will closely work with global teams within the business as well as key matrixed functions across Donaldson such as sales, product management, operations, manufacturing, supply chain, corporate technology, and advanced manufacturing technology. This role will be based at our headquarters in Bloomington, MN. Role Responsibilities: Partner in collaborative setting on strategic vision(s) of focus areas, driving competitive advantage and execution. Conduct customer conversations and develop products based on application and feedback received Provide critical evaluation of concept performance vs customer need and competitive benchmarking Be a trusted engineering consultant in customer-facing situations Produce a steady stream of technical improvements, which enable and recognize continuous product leadership Communicate status updates to senior management within the context of a structured phase-gate process Research and identify market trends and needs to be used to improve Donaldson's quality, safety, and product offering, Minimum Qualifications: BS in Mechanical Engineering, or related engineering field 7+ year experience in new product development or manufacturing engineering Experience in writing and executing product validations in a regulated industry Engineering, process development, or manufacturing experience in a cleanroom environment Familiarity with FDA, GMP, USP, ISO13485 (as examples) regulatory and validation needs Preferred Qualifications: 5+ year working in product development of regulated industry Plastics/polymer molding, bonding and assembly experience Background working with filtration products or single use plastics Experience with medical device or bioprocessing systems components a strong plus Understanding of regulatory requirements in medical device and emerging life science applications Ability to effectively operate within a team composed of and lead from differing locations Travel: Minimal, up to 10% Key words: Medical Device, Engineer, New Product Development, Regulatory, Plastics, Polymer Molding, bioprocessing, FDA, ISO, GMP #LI-Hybrid Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law. Donaldson is an equal opportunity employer. Qualified applicants will receive consideration for employment without regar to race, color, age, gender, religion, national origin, genetic information, protected veterans status, sex, sexual orientation, gender identity, disability status, or any other status protected under federal, state or local laws.