Design Engineer - Medical Device Packaging (...

Job Title: Design Engineer - Medical Device Packaging (Thermoforming) Location: Huntley, IL Employment Type: Full-Time Work Arrangement: Onsite Travel: Up to 20% Position Overview A manufacturing organization specializing in medical device packaging is seeking a Design Engineer to lead the design and development of thermoformed sterile packaging solutions. This role focuses on transforming customer and regulatory requirements into compliant, manufacturable, and high-performance medical packaging products. The Design Engineer will work closely with tooling, production, quality, and regulatory teams to ensure packaging designs meet FDA and ISO standards while supporting efficient commercialization. This is a hands-on, onsite role ideal for someone with experience in thermoformed medical packaging who thrives in a regulated environment. Key Responsibilities Design thermoformed sterile medical packaging products from concept through production using CAD software (SolidWorks preferred) Translate customer, clinical, and regulatory requirements into compliant packaging designs Develop detailed 3D models, assemblies, and 2D drawings Utilize 3D scanning and 3D printing for prototyping, validation, and rapid design iteration Select materials based on performance, sterilization compatibility, sustainability, and cost Conduct feasibility studies including draft analysis, stackability, and functional integrity Collaborate with tooling and manufacturing teams to ensure designs are manufacturable and scalable Partner with quality and regulatory teams to ensure compliance with FDA, ISO 13485, ISO 11607, GMP, and ASTM standards Support packaging validation activities including IQ/OQ/PQ documentation and testing Participate in customer and internal design reviews and technical discussions Identify design, material, or process risks early and develop mitigation strategies Maintain accurate design documentation and manage revisions using PDM/PLM systems Stay current on materials, sterilization methods (EtO, gamma, e-beam), and medical packaging trends Qualifications Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or a related field Minimum of 2 years of packaging design experience, with required experience in medical device packaging Hands-on experience designing thermoformed sterile packaging Strong understanding of thin-gauge thermoforming principles (draft angles, wall thickness, undercuts) Knowledge of materials such as PETG, HIPS, PP, PVC, or similar plastics used in sterile barrier systems Proficiency with 3D CAD software (SolidWorks strongly preferred) Familiarity with production tooling processes and design-for-manufacturing principles Working knowledge of FDA, ISO 13485, ISO 11607, GMP, and ASTM standards Experience supporting validation activities (IQ/OQ/PQ) Ability to manage multiple projects in a regulated, fast-paced environment Strong problem-solving, communication, and documentation skills Preferred Experience Experience designing thermoformed trays, sterile barrier systems, or pharmaceutical packaging Familiarity with cleanroom manufacturing environments Exposure to regulatory audits Understanding of human factors and usability in medical packaging design #IND1 #ZR

Created: 2026-03-04