Packaging Engineer – Medical Devices

We are seeking a Packaging Engineer to support the design and development of sterile packaging systems for medical devices. This position will manage packaging development activities from initial requirements through design validation, documentation, and manufacturing support.

Key Responsibilities

• Design and develop sterile packaging systems, including cases and trays used for steam-sterilized medical devices.
• Create packaging designs and engineering drawings using CREO.
• Develop test protocols and reports for packaging characterization and validation.
• Manage project schedules, deliverables, design reviews, and packaging development milestones.
• Own and maintain Design History File documentation, including design inputs, outputs, risk assessments, and validation records.
• Ensure packaging systems meet ISO 11607, applicable ASTM/ISTA standards, FDA requirements, and EU MDR expectations.
• Evaluate packaging protection against moisture, temperature changes, chemicals, handling, transportation, and tampering.
• Support sterilization, usability, labeling, change control, manufacturing, and packaging-related issue resolution.
• Review existing technical files and recommend remediation to meet current regulatory and documentation standards.
• Collaborate with Quality, Regulatory, Manufacturing, R&D, and other cross-functional teams.

Required Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Professional or internship experience in packaging engineering; approximately 2–7 years of experience preferred.
• Experience designing packaging for medical devices or other regulated products.
• Knowledge of sterile packaging, preferably cases or trays used in steam sterilization.
• Strong proficiency with CREO drawing and design software.
• Project management experience, including timeline and deliverable management.
• Experience owning or contributing to Design History Files.
• Excellent technical documentation, reporting, and file-organization skills.

Preferred Qualifications

• Knowledge of ISO 11607-1 and ISO 11607-2.
• Experience with terminally sterilized medical device packaging and sterile barrier systems.
• Familiarity with steam, ethylene oxide, or radiation sterilization methods.
• Understanding of FDA 21 CFR Part 820, GMP, EU MDR, ASTM, and ISTA requirements.
• Experience with packaging validation, process validation, and risk management.
• Familiarity with SolidWorks, Minitab, Six Sigma, or Design for Six Sigma tools.