Packaging Design Engineer

About the role

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.

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.

Requirements

• 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.
• Familiarity with material properties relevant to PETG, HIPS, PP, or similar plastics used in sterile barrier systems.
• 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.

Qualifications

• Proven track record of success in packaging design and development.
• Strong analytical and problem-solving skills.
• Excellent interpersonal and communication skills.
• Ability to work independently and as part of a team.
• Passion for innovation and continuous improvement.

Skills

• Thermoformed packaging design.
• Material selection and evaluation.
• Feasibility studies and risk assessment.
• Collaboration with cross-functional teams.
• Regulatory compliance and documentation.
• Customer interaction and presentation skills.

Benefits

• Paid time off (PTO)
• Group health and dental insurance
• 401(k) retirement plan

Pay

$85k - $100k

Schedule

Onsite position out of our Huntley, IL Facility