Design Engineer (Direct Hire)
Onsite - Huntley, IL Job Requisition: 7570
Annual Salary Range: $75,000 - $100,000. Individual salaries are based on education, geographic location, and alignment to the market data.
SUMMARY
The Design Engineer will lead the design and development of thermoformed medical packaging products, transforming customer requirements into manufacturable, compliant, and high-performance sterile packaging solutions. This role emphasizes innovative product design, strong cross-functional collaboration with quality and regulatory teams, and proactive risk management to ensure the successful commercialization of safe and effective packaging systems.
RESPONSIBILITIES
- Design thermoformed sterile packaging products from concept through production using CAD software (SolidWorks).
- Translate customer and regulatory specifications into innovative, compliant packaging designs.
- Develop detailed 3D models, assemblies, and 2D drawings for medical packaging products.
- Utilize 3D scanning and 3D printing technologies to support prototype development, design validation, and rapid iteration.
- Evaluate and select materials aligned with performance, sterilization compatibility, sustainability, and cost objectives.
- Conduct feasibility studies including draft analysis, stackability, and functional integrity of sterile packaging systems.
- Collaborate closely with Tool Design Engineering and production teams to ensure designs are practical, efficient, and manufacturable.
- Work with quality and regulatory teams to ensure compliance with FDA, ISO 13485, and GMP requirements.
- Support packaging validation activities, including sample production, functional testing, and documentation for IQ/OQ/PQ.
- Participate in customer and internal meetings to understand needs, present design concepts, and refine solutions.
- Identify potential design, material, or process risks early in the project lifecycle, and proactively develop mitigation strategies.
- Maintain accurate design documentation and manage revisions through PDM/PLM systems.
- Stay current with materials, sterilization methods (EtO, gamma, e-beam), design trends, and technologies relevant to medical packaging.
REQUIREMENTS
- MUST HAVE Packaging Experience in the Medical Device focused on Design Engineering (Thermoforming)
- 2+ years of experience in packaging design of thermoformed or plastic medical device packaging.
- Strong knowledge of design principles for thin-gauge thermoformed packaging, including draft angles, wall thickness, and undercuts.
- Understanding of material properties relevant to PET, HIPS, PVC, or similar plastics.
- Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or related field.
- Proficiency with 3D CAD software (SolidWorks strongly preferred).
- Understanding of material properties relevant to PETG, HIPS, PP, or similar plastics used in sterile barrier systems.
- Familiarity with production tooling processes and ability to integrate packaging design considerations with tooling and manufacturing requirements.
- Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging.
- Ability to identify risks during design and commercialization phases and develop effective mitigation strategies.
- Excellent problem-solving and communication skills with attention to both functionality and usability.
- Ability to manage multiple projects and meet deadlines in a regulated, dynamic environment
- Experience designing thermoformed trays, sterile barrier systems, or pharmaceutical packaging.
- Familiarity with packaging validation protocols (IQ/OQ/PQ) and documentation practices.
- Experience with cleanroom manufacturing and regulatory audits.
- Understanding of human factors and usability in medical packaging design.
Benefits for Senior R&D Engineer:
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Retirement
- Paid Time Off
