Design Engineer

Job Description: Design Engineer - Medical Packaging

We are looking for a Design Engineer with hands-on experience in medical device packaging, specifically focused on thermoforming design. This role is ideal for someone who enjoys creating innovative packaging solutions that meet strict regulatory standards while ensuring functionality and manufacturability.

Key Responsibilities

• Design and develop thermoformed sterile packaging from concept to production using CAD tools (SolidWorks preferred).
• Convert customer and regulatory requirements into practical, compliant packaging designs.
• Create detailed 3D models, assemblies, and 2D drawings for medical packaging components.
• Use 3D scanning and printing to support prototypes, design validation, and quick iterations.
• Select appropriate materials considering performance, sterilization compatibility, sustainability, and cost.
• Perform feasibility studies, including draft analysis, stackability, and functional integrity of packaging systems.
• Collaborate with tooling and manufacturing teams to ensure designs are efficient and ready for production.
• Work closely with quality and regulatory teams to meet FDA, ISO 13485, and GMP standards.
• Support packaging validation activities, including sample builds, functional testing, and documentation for IQ/OQ/PQ.
• Participate in meetings with internal teams and customers to present concepts and refine designs.
• Identify potential risks in design, materials, or processes early and develop mitigation strategies.
• Maintain accurate documentation and manage revisions through PDM/PLM systems.
• Stay updated on materials, sterilization methods (EtO, gamma, e-beam), and trends in medical packaging.

Requirements

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or related field.
• 2+ years of experience in packaging design, preferably for medical devices.
• Strong knowledge of thin-gauge thermoformed packaging principles, including draft angles, wall thickness, and undercuts.
• Understanding of material properties for plastics like PETG, HIPS, PP, or similar used in sterile barrier systems.
• Proficiency in 3D CAD software (SolidWorks strongly preferred).
• Familiarity with tooling processes and ability to integrate design with manufacturing requirements.
• Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging.
• Ability to manage multiple projects and meet deadlines in a regulated environment.
• Experience with thermoformed trays, sterile barrier systems, or pharmaceutical packaging.
• Familiarity with packaging validation protocols (IQ/OQ/PQ) and cleanroom manufacturing.
• Strong problem-solving and communication skills.

Preferred Skills

• Experience with risk management during design and commercialization phases.
• Understanding of human factors and usability in medical packaging design.
• Knowledge of sterilization methods and their impact on packaging materials.