Onsite Packaging Engineer – Medical Devices & Labeling

BioHorizons; Hoover (AL); Hybrid; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical plans

HSA/FSA

Dental insurance

Wellness program

401k with match

Paid holidays

Job summary

BioHorizons in Hoover, AL is seeking a Packaging Engineer for onsite work. The role leads packaging development from concept to commercialization, ensuring sterility, labeling integrity, and regulatory compliance with FDA 21 CFR Part 820, EU MDR, and international standards.

The engineer will develop packaging concepts, define specs, and support supplier engagement and process improvements across the product lifecycle. Travel may be required.

Qualifications

• Proficiency in MS Office Suite and device labeling software.
• Experience with CAD design software (e.g. SolidWorks).
• Experience with U.S. FDA, EU MDR and ISO requirements for design controls of medical devices.

Responsibilities

• Contribute to packaging and labeling activities aligned with FDA, MDR, and global regulatory requirements.
• Develop packaging concepts based on product design inputs and manufacturing needs.
• Create and maintain packaging and labeling specifications and support verification/validation activities.
• Develop technical documentation including drawings, routers, and bills of materials.
• Support QC activities through IQ/OQ/PQ and equipment/software qualification.
• Collaborate with cross-functional teams to implement packaging and labeling solutions.

Skills

MS Office Suite

Device labeling software

SolidWorks

Regulatory knowledge

Stakeholder communication

Overnight travel

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Job description

BioHorizons in Hoover, AL is seeking a Packaging Engineer for onsite work. The role leads packaging development from concept to commercialization, ensuring sterility, labeling integrity, and regulatory compliance with FDA 21 CFR Part 820, EU MDR, and international standards.

The engineer will develop packaging concepts, define specs, and support supplier engagement and process improvements across the product lifecycle. Travel may be required.