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Senior Manufacturing Engineer - Injection Molding Focus

Job in North Haven, New Haven County, Connecticut, 06473, USA
Listing for: BioCT Innovation Commons
Full Time position
Listed on 2026-07-16
Job specializations:
  • Engineering
    Quality Engineering, Manufacturing Engineer, Process Engineer
Salary/Wage Range or Industry Benchmark: 102400 - 153600 USD Yearly USD 102400.00 153600.00 YEAR
Job Description & How to Apply Below

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.

A Day in the Life

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).
Minimum Requirements
  • 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.
Nice To Have
  • 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…
Position Requirements
10+ Years work experience
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