Design Engineer

Design Engineer – Medical Packaging

This is a Direct Hire role.

• Design and develop thermoformed sterile packaging from concept through full-scale production using CAD tools such as Solid Works.
• Translate customer requirements and regulatory standards into functional, compliant, and innovative packaging solutions.
• Create detailed 3D models, assemblies, and 2D technical drawings to support development, tooling, and manufacturing.
• Utilize 3D scanning and additive manufacturing technologies to support rapid prototyping, design verification, and iteration.
• Select and evaluate materials based on performance, sterilization compatibility, sustainability objectives, and cost targets.
• Conduct design feasibility assessments, including draft analysis, wall thickness evaluation, stackability, and functional performance of sterile packaging systems.
• Collaborate closely with tooling, manufacturing, and operations teams to ensure designs are efficient, scalable, and production-ready.
• Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, GMP, ISO 11607, ASTM, and other applicable standards.
• Support packaging validation activities, 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 implement mitigation strategies early in the project lifecycle.
• Maintain accurate design documentation and manage revisions using PDM/PLM systems.
• Stay current on emerging materials, sterilization methods (EtO, gamma, e-beam), and trends in medical packaging design.

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or a related field.
• Minimum 2 years of experience in packaging design; medical device or healthcare industry experience strongly preferred.
• Proficiency in 3D CAD software, with Solid Works experience highly preferred.
• Strong understanding of thin-gauge thermoforming principles, including draft angles, wall thickness control, and undercut design.
• Working knowledge of plastics commonly used in sterile barrier systems (e.g., PETG, HIPS, PP).
• Experience collaborating with tooling and manufacturing teams to ensure design-for-manufacturability.
• Familiarity with medical packaging regulations and standards, including FDA, ISO 11607, ASTM, and ISO 13485.
• Demonstrated ability to assess design and commercialization risks and implement effective mitigation plans.
• 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.
• Working knowledge of packaging validation processes (IQ/OQ/PQ) and supporting documentation.
• Exposure to cleanroom manufacturing environments and regulatory audits.
• Understanding of human factors and usability principles in medical packaging design.