Principal Manufacturing Engineer - Injection Molding

We anticipate the application window for this opening will close on - 24 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 This specialized Principal Manufacturing & Injection Molding Engineer role bridges advanced plastics processing with regulated medical device manufacturing. This position owns the entire lifecycle of finished devices which includes bioabsorbable components — from initial tooling design and scientific process development to component assemblies, equipment qualification, and final packaging. A critical differentiator for this role is deep technical expertise in handling highly sensitive absorbable/bioresorbable polymers (such as PLA, PGA, and PLGA) within an ISO 13485 / FDA-regulated cleanroom manufacturing environment. 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. Establish, optimize, and document robust, repeatable injection molding processes utilizing Scientific Molding principles and Design of Experiments (DOE). Manage strict process controls tailored to bioabsorbable resins. Optimize parameters to minimize Inherent Viscosity (IV) loss, strictly control material residence time, and prevent thermal degradation. Lead Design for Manufacturability (DFM) reviews for complex, multi-cavity, and micro-molding tools. Partner with toolmakers to oversee mold construction, modifications, and steel resizing. Team with manufacturing and quality personnel on a daily basis to review / disposition production defects and provides potential process and/or equipment corrective actions to assure production schedules and quality expectations are met.   Review product field returns to determine root cause of potential manufacturing defects then develop and implement effective corrective actions.  Create and execute engineering studies, DOE, Bill of material updates, and validation documentation for accuracy, statistical validity, and compliance.  Served as lead engineer for molding and automated assembly equipment design specifications, request for quotes, vendor selection activities, equipment design review, FAT, SAT, and validation activities. Lead Capacity Expansion and Process Improvement Projects to increase yields, reduce scrap, and Improve Product Quality Author standard operating procedures (SOPs), design custom manufacturing fixtures, and train operators and technicians on new production lines. Author and execute comprehensive validation protocols (IQ/OQ/PQ) for molding machines, automated and manual assemblies, and multi-cavity molds in compliance with FDA 21 CFR Part 820. Lead risk assessment activities, including the creation and maintenance of PFMEAs. Conduct root-cause investigations for production anomalies, owning the execution of Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA).

Bachelor's degree with a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with a minimum of 3 years relevant experience.

Minimum of 5 - 7 years of injection molding experience, preferably in a regulated manufacturing