Validation Engineer

Job Title: Validation Engineer – Injection MoldingLocation: Minnesota (MN) / Michigan (MI)Duration: 12 monthsPosition Summary:We are seeking a detail-oriented Validation Engineer with injection molding experience to support validation and qualification activities within a regulated medical device manufacturing environment. This role will focus on process and equipment validation of injection molding systems, ensuring compliance with FDA and ISO standards while supporting high-quality, reliable product manufacturing.Key Responsibilities:Lead and execute validation activities for injection molding machines, tooling, and auxiliary equipment (e.g., dryers, chillers, robots).Develop, review, and execute validation protocols including IQ, OQ, PQ, FAT, and SAT.Perform process validation and characterization studies for molded components, including capability and stability analysis.Support validation of new production lines and transfer projects involving injection-molded medical components.Collaborate with tooling, manufacturing, and quality teams to troubleshoot molding process issues and improve cycle time and product quality.Conduct risk assessments (FMEA) and support deviation investigations, CAPA, and change control activities.Author and maintain validation documentation including Validation Master Plans (VMP), protocols, reports, and traceability matrices.Support cleanroom and environmental qualifications as required for molding operations.Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.Drive continuous improvement initiatives for molding processes, yield, and efficiency.Provide technical support during audits and inspections.Required Qualifications:Bachelor’s degree in Mechanical, Biomedical, Chemical, or Industrial Engineering (or related field).Minimum 3+ years of validation experience in the medical device industry.Hands-on experience with injection molding processes (thermoplastics/silicone preferred).Strong experience in equipment qualification and process validation lifecycle (IQ/OQ/PQ).Knowledge of tooling, mold qualification, and scientific molding principles.Experience working in FDA-regulated and ISO 13485-compliant environments.Strong understanding of GxP documentation, change control, and validation documentation practices.Proficiency in data analysis tools (Excel, Minitab, or similar).Preferred Qualifications:Experience with automation systems, robotics, or vision inspection systems in molding environments.Knowledge of DOE, statistical analysis, Cp/Cpk, and process capability studies.Familiarity with SAP, MES, or electronic quality management systems (eQMS).Experience with cleanroom molding environments (ISO Class 7/8).Certification in Lean, Six Sigma, or Scientific Molding is a plus.Key SkillsInjection Molding ValidationProcess Characterization & OptimizationEquipment Qualification (IQ/OQ/PQ)Root Cause Analysis & CAPARegulatory Compliance (FDA, ISO 13485, GMP)Cross-functional CollaborationTechnical Documentation & Reporting