ThreePDS Inc. · 4 weeks ago
Design Engineer – Medical Device Packaging (Thermoforming)
Huntley, IL
Full-time
Onsite
Entry, Mid Level
$85K/yr - $100K/yr
2+ years expThreePDS Inc. is a manufacturing organization specializing in medical device packaging, seeking a Design Engineer to lead the design and development of thermoformed sterile packaging solutions. The role involves transforming customer and regulatory requirements into compliant, manufacturable, and high-performance medical packaging products while ensuring compliance with FDA and ISO standards.
ConsultingHuman ResourcesProfessional ServicesRecruitingStaffing Agency
Responsibilities
Design thermoformed sterile medical packaging products from concept through production using CAD software (SolidWorks preferred)
Translate customer, clinical, and regulatory requirements into compliant packaging designs
Develop detailed 3D models, assemblies, and 2D drawings
Utilize 3D scanning and 3D printing for prototyping, validation, and rapid design iteration
Select materials based on performance, sterilization compatibility, sustainability, and cost
Conduct feasibility studies including draft analysis, stackability, and functional integrity
Collaborate with tooling and manufacturing teams to ensure designs are manufacturable and scalable
Partner with quality and regulatory teams to ensure compliance with FDA, ISO 13485, ISO 11607, GMP, and ASTM standards
Support packaging validation activities including IQ/OQ/PQ documentation and testing
Participate in customer and internal design reviews and technical discussions
Identify design, material, or process risks early and develop mitigation strategies
Maintain accurate design documentation and manage revisions using PDM/PLM systems
Stay current on materials, sterilization methods (EtO, gamma, e-beam), and medical packaging trends
Qualification
Required
Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Design, or a related field
Minimum of 2 years of packaging design experience, with required experience in medical device packaging
Hands-on experience designing thermoformed sterile packaging
Strong understanding of thin-gauge thermoforming principles (draft angles, wall thickness, undercuts)
Knowledge of materials such as PETG, HIPS, PP, PVC, or similar plastics used in sterile barrier systems
Proficiency with 3D CAD software (SolidWorks strongly preferred)
Familiarity with production tooling processes and design-for-manufacturing principles
Working knowledge of FDA, ISO 13485, ISO 11607, GMP, and ASTM standards
Experience supporting validation activities (IQ/OQ/PQ)
Ability to manage multiple projects in a regulated, fast-paced environment
Strong problem-solving, communication, and documentation skills
Preferred
Experience designing thermoformed trays, sterile barrier systems, or pharmaceutical packaging
Familiarity with cleanroom manufacturing environments
Exposure to regulatory audits
Understanding of human factors and usability in medical packaging design
Company
ThreePDS Inc.
At ThreePDS, we provide the highest quality staffing solutions on contract and/or permanent basis within the framework of a highly personalized and transparent approach.
51-200 employees
H1B Sponsorship
ThreePDS Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Julie Philipose
Talent Acquisition Partner
Company data provided by crunchbase