Design Engineer

Design Engineer – Medical Packaging The Design Engineer is responsible for leading the design and development of thermoformed medical packaging solutions that meet customer, regulatory, and manufacturing requirements. This role translates complex needs into compliant, reliable, and manufacturable sterile packaging systems while emphasizing innovation, cross‑functional collaboration, and early risk mitigation to support successful product launches. Key Responsibilities Design and develop thermoformed sterile packaging from concept through full‑scale production using CAD tools such as SolidWorks. 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. Qualifications 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 SolidWorks 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. Preferred Experience 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. For more information, contact Robby Nardini at View email address on click.appcast.io. #J-18808-Ljbffr Saigepartners