Principal Process Engineer, Advanced Manufacturing Technical Lead
MedTechPharmaBiotechRegulatory AffairsQuality Assuranceheoremacroinform
Job description
We anticipate the application window for this opening will close on - 23 Sep 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 Principal Process Engineer in AME organization. As a Principal Process Engineer on Medtronic’s Advanced Manufacturing Engineering (AME) team, you will combine broad, hands-on engineering experience with strong technical leadership to support the development, commercialization, and scale-up of life-saving medical technologies. In this role, you will apply a well-rounded background across manufacturing processes, equipment, materials, process development, validation, and continuous improvement to solve complex challenges and guide engineering decisions. You will connect product requirements with practical manufacturing solutions, supporting programs from early development through production. You will also help strengthen the team’s technical capabilities by mentoring engineers, coaching structured problem-solving, sharing knowledge, and guiding cross-functional teams. Success requires technical depth, the ability to work across engineering disciplines, and a collaborative leadership approach that builds confidence, accountability, and sound engineering judgment in others. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges in a manufacturing environment are invaluable to our work. This role requires working onsite a minimum of five days per week to support professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Responsibilities: Provide hands-on technical leadership across process development, equipment selection and integration, process characterization, validation, technology transfer, and manufacturing optimization. Apply broad engineering knowledge to evaluate how materials, equipment, tooling, process parameters, and product design interact to influence manufacturing performance. Lead complex engineering initiatives from concept through implementation, balancing product requirements, quality, manufacturability, scalability, cost, and project timelines. Partner with R&D, Quality, Operations, Supply Chain, Regulatory Affairs, and external partners to resolve technical challenges and support successful new product introductions and ongoing manufacturing. Evaluate manufacturing approaches and emerging technologies, including automation and digital manufacturing capabilities, and recommend solutions appropriate to the application. Lead process characterization and establish effective process controls using Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, and data-driven decision-making. Guide process risk assessments, validation strategies, and execution of IQ/OQ/PQ activities in accordance with applicable quality system and regulatory requirements. Lead investigations into complex manufacturing issues, working directly with teams to identify root causes, evaluate solutions, and implement sustainable corrective and preventive actions. Mentor and coach engineers across experience levels, helping them strengthen technical skills, troubleshooting approaches, engineering judgment, and project ownership. Review engineering studies, technical documentation, and proposed solutions; provide constructive feedback and help teams understand the reasoning behind technical decisions. Foster a collaborative environment where engineers ask questions, share knowledge, challenge assumptions respectfully, and learn from project outcomes. Lead through influence by aligning cross-functional teams on technical priorities, communicating tradeoffs clearly, and guiding decisions when requirements or solutions are uncertain. Contribute to manufacturing technology roadmaps, capital planning, equipment selection , and expansion strategies, while sharing lessons learned and best practices across teams and sites. Must Have: Minimum Requirements Bachelor’s degree with a minimum of 7 years of relevant experience. OR Advanced degree with a minimum of 5 years of relevant experience. Nice to Have: Preferred Qualifications Broad, hands-on engineering experience spanning multiple areas of manufacturing, such as process development, equipment and tooling, materials processing, validation, production support, and continuous improvement. Experience in medical device , pharmaceutical , biotechnology, or other highly regulated manufacturing environments. Demonstrated ability to work across multiple manufacturing technologies and apply engineering fundamentals to unfamiliar processes or technical challenges. Experience with plastics processing, including injection molding or extrusion, complex assembly processes, automation, robotics, or equipment integration. Experience supporting products through multiple lifecycle stages, from development and commercialization to manufacturing scale-up and ongoing process optimization. Demonstrated tec
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