Design Engineer, Packaging (Medtech)

TL;DR

Design Engineer, Packaging (Medtech): Design and development of medical device packaging and sterilization cases with an accent on qualification, testing, and process validation. Focus on defining design inputs, preparing material specifications, and ensuring compliance with FDA and ISO standards.

Location: Onsite in Gainesville, FL

Company

hirify.global is an innovative company focused on developing revolutionary orthopedic implants and instruments to optimize the surgical experience and improve patient outcomes.

What you will do

• Design and develop packaging or sterilization case components for new and existing medical products.
• Define design input requirements by consulting with stakeholders, including end-users, sales, and quality personnel.
• Prepare technical specifications for raw materials, components, and manufacturing processes.
• Execute test protocols and document sterile product bills of materials and shelf life.
• Establish and manage project plans, including task definition, dependencies, and scheduling.
• Maintain Design History Files and support regulatory submissions through validation and testing.

Requirements

• Bachelor’s degree from an accredited institution.
• Practical knowledge of medical-device packaging or sterilization case systems.
• Understanding of mechanical drafting, GD&T, and CAD applications.
• Familiarity with FDA/ISO requirements and orthopedic implants/instruments.
• Competency in statistical analysis and technical writing.
• Must be able to work onsite in Gainesville, FL

Culture & Benefits

• Work in an environment dedicated to cutting-edge innovation in orthopedic technology.
• Collaborate across cross-functional teams including Manufacturing, Quality, and Marketing.
• Opportunity to develop products that directly impact patient mobility and freedom.

Hiring process

• Initial Interview.
• Hiring Manager and Team Interview(s).
• Final Selection and Offer.