Design Engineer

Job Description

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This is a Direct Hire role.

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

Bachelors 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.

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Saige Partners one of the fastest growing technology and talent companies in the Midwest believes in people with a passion to help them succeed. We are in the business of helping professionals Build Careers Not Jobs . Saige Partners believes employees are the most valuable asset to building a thriving and successful company culture . Contact us to learn more about the opportunity below or check ou t other opportunities at Experience :

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Key Skills

Mechanical Design,SOC,System Design,GD&T,CAD,Creo,SolidWorks,Mechanical Engineering,Perl,Autocad,HVAC Design,Catia

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 85000 - 95000