Senior Manufacturing Engineer - Injection Molding Focus at COV Covidien LP — North Haven, CT

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.

• 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 manufacturing process experience, Mold Operation, Mold design, Mold Maintenance, Mold Flow analysis,
• Experience in automated machine design, repair, and troubleshooting.
• Solid presentation and computer skills (Excel /Word / PowerPoint/ Projects/ AutoCAD/ SolidWorks, etc.)
• Strong background in Statistical Process Control (SPC), Minitab, and data analysis to evaluate process capability (Cpk).
• Project management skills to keep projects on track
• Self-motivated attitude with the ability to multitask and thrive in a fast-paced environment
• Excellent Interpersonal communication skills
• Solid working knowledge of ISO 13485, ISO 14644 (cleanroom standards), and FDA medical device manufacturing regulations.

Physical Job Requirements

U.S. Work Authorization & Sponsorship

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Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$102,400.00 - $153,600.00