Design Engineer

The Design Engineer is responsible for driving the design and development of thermoformed medical packaging solutions, converting customer and regulatory requirements into manufacturable, compliant, and reliable sterile packaging systems. This role focuses on creative problem-solving, cross-functional collaboration, and early risk identification to support the successful launch of safe, high-quality packaging products.

Key Responsibilities

• Design and develop thermoformed sterile packaging from initial concept through full-scale production using CAD tools such as SolidWorks.
• Interpret customer needs and regulatory requirements to create compliant, functional, and innovative packaging solutions.
• Produce detailed 3D models, assemblies, and 2D technical drawings to support development and manufacturing.
• Leverage 3D scanning and additive manufacturing to support prototyping, design verification, and rapid iteration.
• Select and evaluate materials based on performance requirements, sterilization compatibility, sustainability goals, and cost considerations.
• Perform design feasibility assessments, including draft analysis, stackability, and overall functional performance of sterile packaging systems.
• Partner with tooling and manufacturing teams to ensure designs are practical, efficient, and optimized for production.
• Collaborate with quality and regulatory groups to ensure alignment with FDA, ISO 13485, GMP, and other applicable standards.
• Support packaging validation efforts, including sample builds, functional testing, and preparation of IQ/OQ/PQ documentation.
• Participate in customer-facing and internal meetings to gather requirements, present design concepts, and refine solutions.
• Proactively identify design, material, and process risks, and develop mitigation plans early in the project lifecycle.
• Maintain accurate design records and manage revisions using PDM/PLM systems.
• Stay informed on new materials, sterilization technologies (EtO, gamma, e-beam), and emerging trends in medical packaging design.

Qualifications

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or a related discipline.
• Minimum of 2 years of experience in packaging design, preferably within the medical device or healthcare industry.
• Proficiency in 3D CAD software, with SolidWorks experience strongly preferred.
• Solid understanding of thin-gauge thermoforming principles, including draft angles, wall thickness, and undercut design.
• Knowledge of plastic materials commonly used in sterile barrier systems, such as PETG, HIPS, and PP.
• Experience collaborating with tooling and manufacturing teams to ensure designs align with production requirements.
• Familiarity with medical packaging standards and regulations, including FDA, ISO 11607, ASTM, and ISO 13485.
• Strong ability to assess risks during design and commercialization phases and implement effective mitigation strategies.
• Excellent analytical, problem-solving, and communication skills with a focus on usability and performance.
• Ability to manage multiple projects and meet deadlines in a fast-paced, regulated environment.
• Experience designing thermoformed trays, sterile barrier systems, or pharmaceutical packaging is preferred.
• Working knowledge of packaging validation processes (IQ/OQ/PQ) and related documentation.
• Exposure to cleanroom manufacturing environments and regulatory audits is a plus.
• Understanding of human factors and usability principles in medical packaging design.