Packaging and Labeling Engineer (Medical Devices)

TL;DR

Packaging and Labeling Engineer (Medical Devices): Designing and implementing packaging and labeling solutions for medical device products with an accent on regulatory compliance, quality standards, and design controls. Focus on ensuring FDA and ISO compliance, executing packaging validation, and managing risk assessments.

Location: Hybrid in City of Industry, US; fully remote possible for highly qualified candidates. Must have US work authorization (no sponsorship available).

Salary: $120,000 - $155,000 annually

Company

hirify.global provides essential services to the life sciences industry to ensure healthcare products are developed and distributed in compliance with regulatory requirements.

What you will do

• Develop, review, and support packaging and labeling designs for medical device products.
• Ensure all activities comply with FDA regulations, ISO standards, and internal quality systems.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Support design control activities, documentation, and change management processes.
• Perform risk assessments and assist with packaging validation, including protocol development and execution.
• Troubleshoot technical packaging issues and drive deliverables to meet aggressive timelines.

Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, or related technical discipline).
• 5+ years of experience in packaging and/or labeling engineering within the medical device industry.
• Strong knowledge of FDA medical device regulations, design controls, and quality system requirements.
• Familiarity with applicable ISO standards and medical device regulatory frameworks.
• Experience with risk management, change control, and verification/validation processes.
• Must be authorized to work in the US; no sponsorship is available.

Culture & Benefits

• Medical and Sick Time benefits provided for W2 Temp roles.
• Access to tools and coaching for professional growth and development.
• Opportunity to work within a multi-cultural, global team of experts.
• Environment focused on nurturing talent and professional passions.