Senior Manufacturing Engineer - Injection Molding Focus

A Day in the Life

This specialized Senior Manufacturing & Injection Molding Engineer role bridges advanced plastics processing with regulated medical device manufacturing. The position owns the entire lifecycle of finished devices which includes bio‑absorbable components—from initial tooling design and scientific process development to component assemblies, equipment qualification, and final packaging. The role requires deep technical expertise in handling highly sensitive absorbable/bioresorbable polymers (e.g., PLA, PGA, PLGA) within an ISO 13485/FDA‑regulated cleanroom manufacturing environment.

The employee is required to work in‑person at least five days a week to foster professional growth and cross‑functional collaboration.

• 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 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.
• Collaborate daily with manufacturing and quality personnel to review/disposition production defects and provide potential process or equipment corrective actions to assure production schedules and quality expectations.
• Review product field returns to determine root cause of potential manufacturing defects and 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.
• Serve 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 four years of relevant experience.
• OR Master’s degree with a minimum of two years of relevant experience.
• OR PhD with zero years of relevant experience.

• Minimum of 3–4 years of injection molding experience, preferably in a regulated manufacturing environment.
• Bachelor’s or advanced degree in Plastics Engineering, Polymer Engineering, Manufacturing Engineering, or Mechanical Engineering.
• Proven track record working with bio‑absorbable or resorbable polymers (PLA, PLGA, PGA).
• Demonstrated knowledge of GD&T and PFMEA.
• Significant plastics manufacturing process experience, mold operation, mold design, mold maintenance, and mold flow analysis.
• Experience in automated machine design, repair, and troubleshooting.
• Solid presentation and computer skills (Excel, Word, PowerPoint, Projects, AutoCAD, Solid Works, 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.

The above statements describe the general nature and level of work performed by employees assigned to this position, but they are not an…