Senior Manufacturing Engineer - Injection Molding Focus

About the role

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.

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.
• 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).

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.
• 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.

Qualifications

• 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.

Skills

• Injection molding experience, preferably in a regulated manufacturing environment.
• Experience with bioabsorbable or resorbable polymers (PLA, PLGA, PGA).
• Knowledge of GD&T and PFMEA.
• Significant Plastics manufacturing process experience.
• Experience in automated machine design, repair, and troubleshooting.
• Strong background in Statistical Process Control (SPC), Minitab, and data analysis.
• Project management skills.
• Excellent interpersonal communication skills.
• Working knowledge of ISO 13485, ISO 14644 (cleanroom standards), and FDA medical device manufacturing regulations.

Benefits

Competitive Salary and flexible Benefits Package including Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).