Packaging Engineer
Role: Packaging Engineer II (Medical Device)Location: North Haven, CT (Onsite – 5 Days/Week)Employment Type: W2 ContractDurtion: Aug 2026 – Apr 2027We are seeking a Packaging Engineer II with experience in medical device packaging validation, process validation, and packaging development. This role will focus on validating and qualifying new packaging materials for absorbable suture products while ensuring compliance with FDA and ISO standards.Top Required SkillsPackaging EngineeringProcess Validation (IQ, OQ, PQ)Packaging Validation & QualificationProcess DevelopmentEquipment Qualification (IQ)Packaging Materials (Tyvek, Foil, Nylon Film, Flexible Films)Cognex & Keyence Vision Inspection SystemsProject Leadership & Cross-Functional CollaborationKey ResponsibilitiesLead packaging validation for new packaging materials.Perform Equipment Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Execute the complete Process Validation Lifecycle, from process characterization through PQ.Develop validation protocols, reports, and engineering documentation.Support packaging process development and continuous improvement initiatives.Work with Cognex and Keyence vision inspection systems.Create SOPs, support change control activities, and ensure GMP compliance.Collaborate with Manufacturing, Quality, Validation, and R&D teams to deliver projects on time.Required QualificationsBachelor's Degree in Packaging, Mechanical, Manufacturing, or related Engineering.3–5 years of experience in:Packaging EngineeringMedical Device ManufacturingProcess ValidationPackaging ValidationEquipment QualificationExperience with IQ, OQ, PQ, process development, and validation documentation.Preferred SkillsDOE (Design of Experiments) using MinitabComputer System Validation (CSV)SOP DevelopmentMedical Device Change ControlFDA 21 CFR Part 820EU MDR (2017/745)ISO 13485, ISO 14971, IEC 60601GMP DocumentationMicrosoft Office (Excel, Word, PowerPoint)KeywordsPackaging Engineer | Medical Device | Packaging Validation | Process Validation | IQ | OQ | PQ | Equipment Qualification | Packaging Development | Tyvek | Foil | Nylon Film | Cognex | Keyence | DOE | Minitab | CSV | SOP | GMP | FDA 21 CFR Part 820 | ISO 13485 | EU MDR | Change Control | Manufacturing Engineering