Medical Packaging Design Engineer – Thermoformed

Saigepartners; Chicago (IL); Ibrido; USD 80.000 - 115.000; Tempo pieno

Descrizione del lavoro

Saige Partners in Chicago is seeking a Design Engineer to lead the design and development of thermoformed medical packaging that meets customer, regulatory, and manufacturing needs. You will translate requirements into compliant, manufacturable sterile packaging, using SolidWorks, 3D scanning, and additive manufacturing for rapid prototyping, while collaborating with tooling, regulatory, and quality teams.

The role emphasizes risk mitigation, design-for-manufacturability, and staying current on

Competenze

• 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 preferred.
• Proficiency in 3D CAD software, with SolidWorks experience highly preferred.
• Strong understanding of thin-gauge thermoforming principles, draft angles, wall thickness control, and undercut design.
• Working knowledge of plastics used in sterile barrier systems (PETG, HIPS, PP).
• Experience collaborating with tooling and manufacturing teams for design-for-manufacturability.
• Familiarity with medical packaging regulations and standards (FDA, ISO 11607, ASTM, ISO 13485).
• Ability to assess design and commercialization risks and implement mitigation plans.
• Excellent analytical, problem-solving, and communication skills; focus on usability and performance.
• Ability to manage multiple projects and meet deadlines in a regulated environment.

Mansioni

• Design and develop thermoformed sterile packaging from concept through production using CAD tools such as SolidWorks.
• Translate customer requirements and regulatory standards into functional, compliant packaging solutions.
• Create detailed 3D models, assemblies, and 2D drawings to support development, tooling, and manufacturing.
• Utilize 3D scanning and additive manufacturing for rapid prototyping and verification.
• Select and evaluate materials based on performance, sterilization compatibility, sustainability, and cost.
• Conduct design feasibility assessments including draft analysis, wall thickness, stackability, and performance.
• Collaborate with tooling, manufacturing, and operations to ensure scalable, production-ready designs.
• Work with Quality and Regulatory teams to ensure FDA, ISO 13485, GMP, ISO 11607, ASTM compliance; support IQ/OQ/PQ activities.
• Participate in customer meetings to gather requirements and present design concepts.
• Identify risks early and implement mitigation strategies; maintain design documentation in PDM/PLM systems.
• Stay current on materials, sterilization methods (EtO, gamma, e-beam), and trends in medical packaging design.

Conoscenze

Analytical thinking

Communication

Problem solving

Cross-functional collaboration

Formazione

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Design

Strumenti

SolidWorks

PDM/PLM systems

3D scanning

Descrizione del lavoro

Saige Partners in Chicago is seeking a Design Engineer to lead the design and development of thermoformed medical packaging that meets customer, regulatory, and manufacturing needs. You will translate requirements into compliant, manufacturable sterile packaging, using SolidWorks, 3D scanning, and additive manufacturing for rapid prototyping, while collaborating with tooling, regulatory, and quality teams.

The role emphasizes risk mitigation, design-for-manufacturability, and staying current on