Design Engineer

• 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.

Do you have experience in Tooling?, Do you have a Bachelor's degree?, * 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.

Pulled from the full job description

• Tuition reimbursement
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Health savings account
• Dental insurance, At TOPPAN Packaging Americas, We offer a comprehensive Total Rewards package designed to support our employees' overall wellbeing. This includes competitive pay, robust benefits, and programs that help you thrive both personally and professionally. Specific benefits and wellbeing programs may vary based on your work location, employment classification, or collective bargaining agreement., * 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 to recreate, rejuvenate and care for the health of yourself and family
• Variety of company paid and voluntary employee-paid insurance plans including life, personal accident, and disability insurance
• Tuition reimbursement

TOPPAN Packaging Americas specializes in designing and manufacturing sustainable, high-performance flexible and thermoformed packaging solutions for the food, beverage, medical and consumer goods industries. We offer products like transparent high barrier films, pouches, clamshells and trays, utilizing advanced technology to enhance product safety, visibility and environmental sustainability. TOPPAN Packaging Americas operates as part of the global TOPPAN group, with 22 manufacturing facilities across North America, Latin America and Europe., TEQ, a division of Toppan, is a leading provider of innovative thermoformed packaging solutions specifically for the healthcare and medical device industries. Our focus is on designing and producing, medical devices, sterile barrier systems, medical trays, and other critical packaging that meets the highest standards of safety, compliance, and performance. With a commitment to sustainability, regulatory excellence, and customer collaboration, TEQ ensures that life-saving products are delivered in packaging that protects, performs, and enhances patient outcomes