Design Engineer

The Design Engineer will lead the design and development of thermoformed medical packaging products, transforming customer requirements into manufacturable, compliant, and high-performance sterile packaging solutions. This role emphasizes innovative product design, strong cross-functional collaboration with quality and regulatory teams, and proactive risk management to ensure the successful commercialization of safe and effective packaging systems. This position is an onsite position out of our Huntley, IL Facility. Responsibilities Design thermoformed sterile packaging products from concept through production using CAD software (e.g., SolidWorks). Translate customer and regulatory specifications into innovative, compliant packaging designs. Develop detailed 3D models, assemblies, and 2D drawings for medical packaging products. Utilize 3D scanning and 3D printing technologies to support prototype development, design validation, and rapid iteration. Evaluate and select materials aligned with performance, sterilization compatibility, sustainability, and cost objectives. Conduct feasibility studies including draft analysis, stackability, and functional integrity of sterile packaging systems. Collaborate closely with Tool Design Engineering and production teams to ensure designs are practical, efficient, and manufacturable. Work with quality and regulatory teams to ensure compliance with FDA, ISO 13485, and GMP requirements. Support packaging validation activities, including sample production, functional testing, and documentation for IQ/OQ/PQ. Participate in customer and internal meetings to understand needs, present design concepts, and refine solutions. Identify potential design, material, or process risks early in the project lifecycle, and proactively develop mitigation strategies. Maintain accurate design documentation and manage revisions through PDM/PLM systems. Stay current with materials, sterilization methods (EtO, gamma, e-beam), design trends, and technologies relevant to medical packaging. Qualifications Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or related field. 2+ years of experience in packaging design, with a strong preference for medical device packaging. Proficiency with 3D CAD software (SolidWorks strongly preferred). Strong knowledge of thin-gauge thermoformed packaging design, including draft angles, wall thickness, and undercuts. Understanding of material properties relevant to PETG, HIPS, PP, or similar plastics used in sterile barrier systems. Familiarity with production tooling processes and ability to integrate packaging design considerations with tooling and manufacturing requirements. Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging. Ability to identify risks during design and commercialization phases and develop effective mitigation strategies. Excellent problem-solving and communication skills with attention to both functionality and usability. Ability to manage multiple projects and meet deadlines in a regulated, dynamic environment. Experience designing thermoformed trays, sterile barrier systems, or pharmaceutical packaging. Familiarity with packaging validation protocols (IQ/OQ/PQ) and documentation practices. Experience with cleanroom manufacturing and regulatory audits. Understanding of human factors and usability in medical packaging design. Benefits Medical, dental, and vision coverage for you and your dependents, including FSA and HSA options. 401(k) retirement plan with company match. Wellbeing tools and resources to support holistic health, including an Employee Assistance Program with a variety of services. Paid time off and holidays. Variety of company paid and voluntary employee-paid insurance plans including life, personal accident, and disability insurance. Tuition reimbursement. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, veteran or military status, citizenship status, or any other characteristic protected by applicable federal, state, or local laws. We are committed to providing a workplace where everyone feels respected, valued, and able to contribute to their fullest potential. We also provide reasonable accommodations to individuals with disabilities throughout the application and employment processes. If you require assistance or accommodation due to a disability, please contact us. #J-18808-Ljbffr TOPPAN TEQ LLC