Principal Additive Manufacturing Engineer - Warsaw, IN

Medtronic Warsaw, Indiana, United States of America Updated 24 September 2026
MedTechPharmaRegulatory AffairsQuality Assuranceheorgmpemafdaiso 13485croinform

Job description

We anticipate the application window for this opening will close on - 5 Oct 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In this role, you will help bring innovative medical technologies from concept into commercialization by leading manufacturing engineering efforts for metal additive manufacturing processes within New Product Introduction. The Principal Manufacturing Engineer will support both upstream and later-stage NPI activities, partnering closely with cross-functional teams to develop robust, scalable, and compliant manufacturing solutions that enable successful product launches and long-term operational performance. This position requires deep technical expertise in metal additive manufacturing, strong process development capabilities, and experience operating within a regulated environment. The ideal candidate will be equally comfortable supporting early feasibility and design collaboration as well as process validation, design transfer, and production readiness activities. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities may include the following and other duties may be assigned: Lead manufacturing engineering activities for new product introduction (NPI) programs involving metal additive manufacturing technologies. Partner with Product Development during product design and development to incorporate Design for Manufacturability (DFM) and Design for Additive Manufacturing (DfAM) principles into product and process decisions. Support new product introduction activities from concept through commercialization, including feasibility assessments, prototype build strategies, process characterization, manufacturing readiness, design transfer, validation, and product launch execution. Develop, optimize, and scale metal additive manufacturing processes to meet product performance, quality, compliance, capacity, and supply requirements. Define manufacturing methods, process flows, equipment requirements, inspection strategies, capacity assumptions, and manufacturing specifications for new products. Establish and maintain critical process parameters, process controls, process windows, and manufacturing standards to ensure robust and repeatable production. Lead or support equipment qualification, process validation, and manufacturing risk management activities, including IQ, OQ, PQ, PFMEA, control plans, and process capability assessments. Partner with Quality, Regulatory, Operations, Supply Chain, Supplier Quality, Procurement, and other cross-functional stakeholders to support product realization, transfer, and commercialization activities. Conduct root cause investigations and implement corrective actions to resolve development, validation, and early production issues. Author, review, and maintain engineering and quality system documentation, including protocols, reports, procedures, risk assessments, specifications, and engineering changes. Collaborate with internal teams and external manufacturing partners to develop and advance metal additive manufacturing capabilities. Evaluate emerging additive manufacturing technologies, materials, equipment, and post-processing methods to support future business and product needs. Provide technical leadership and mentorship to engineers and cross-functional teams. Required Qualifications Bachelor's degree with a minimum of 7 years of relevant experience. OR a Master's degree with a minimum of 5 years relevant experience. OR a PhD with 3 years relevant experience. Preferred Qualifications Bachelor’s or Master’s degree in Engineering, Materials Science, or a related field. 5+ years of manufacturing engineering, process engineering, or new product introduction experience. Experience with metal additive manufacturing in a product development, process development, or manufacturing environment. Experience supporting early-stage process development, industrialization, and design transfer activities. Experience with metal additive manufacturing technologies, materials, powder handling, material control, and process consistency requirements, including technologies such as laser powder bed fusion. Experience with additive manufacturing post-processing methods such as depowdering, heat treatment, support removal, machining, cleaning, inspection, and surface finishing. Experience applying Design for Additive Manufacturing (DfAM) and Design for Manufacturability (DfM) principles. Experience with process validation, equipment qualification, manufacturing documentation, PFMEA, control plans, nonconformance investigations, and CAPA activities in a regulated or highly controlled environment. Experience applying structured problem-solving, risk management, process control, DOE, statistical analysis, process capability studies, and data-driven process optimization. Experience working on cross-functional teams and managing multiple technical priorities. Experience in medical device manufacturing. Familiarity with FDA, ISO 13485, GMP, and related regulatory and quality system requirements. Lean Six Sigma certification or experience leading continuous improvement initiatives. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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. U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work author

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