Senior Manufacturing Engineer - Injection Molding Focus
Listed on 2026-07-16
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Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer
We anticipate the application window for this opening will close on 15 Jul 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.
This specialized Senior 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- 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 4 years of relevant experience.
- OR Master's degree with a minimum of 2 years relevant experience.
- OR PhD with 0 years relevant experience.
- Minimum of 3–4 years of injection molding experience, preferably in a regulated manufacturing environment, highly preferred.
- Bachelor’s or advanced degree in Plastics Engineering, Polymer Engineering, Manufacturing Engineering, or Mechanical Engineering.
- Proven track record working with bioabsorbable or resorbable polymers (PLA, PLGA, PGA) is highly preferred.
- Demonstrated knowledge of GD&T and PFMEA.
- Significant Plastics…
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