Cette offre d'emploi n'est plus disponible
À propos
We strive to be Your Future, Your Solution to accelerate your career!
Contact Robby Nardini at rnardini@saigepartners.com or , you can also schedule an appointment at to learn more about this opportunity!
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
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.
Learn more about Saige Partners on Facebook or LinkedIn.
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 out other opportunities at https://careers.saigepartners.com/.
Meet Your Recruiter
Robby Nardini
Compétences linguistiques
- English
Avis aux utilisateurs
Cette offre a été publiée par l’un de nos partenaires. Vous pouvez consulter l’offre originale ici.