Onsite Medical Device Packaging & Labeling Engineer

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

Benefits offered by this job

Medical plans

401(k) matching

Paid time off

Parental leave

Life insurance

Job summary

BioHorizons in Hoover, AL is seeking a Packaging Engineer to design, develop, and manage packaging and labeling for medical devices. You will ensure compliance with FDA 21 CFR Part 820, EU MDR, and international standards, leading packaging development from concept through commercialization.

You will define verification/validation strategies for packaging performance, sterility, and distribution robustness, while supporting labeling content, UDI, and global regulatory alignment across product

Qualifications

• Bachelor's degree in Engineering required; Mechanical or Biomedical preferred.
• 4–8 years of experience as a Medical Device Engineer (Packaging/Manufacturing preferred).
• Experience with FDA/ISO design controls and EU MDR is required.

Responsibilities

• Lead packaging and labeling activities per FDA/EU MDR and other global standards.
• Develop packaging concepts based on product design inputs and manufacturing needs.
• Create and maintain packaging specifications; support verification and validation.
• Prepare technical docs including drawings, routers, and BOMs.
• Collaborate with QA, Regulatory, Regulatory Affairs, and manufacturing teams.

Skills

Regulatory knowledge

Stakeholder communication

Travel readiness

Education

Bachelor's degree in Engineering (Mechanical or Biomedical)

4–8 years of medical device packaging experience

Tools

MS Office Suite

Device labeling software

SolidWorks CAD

Job description

BioHorizons in Hoover, AL is seeking a Packaging Engineer to design, develop, and manage packaging and labeling for medical devices. You will ensure compliance with FDA 21 CFR Part 820, EU MDR, and international standards, leading packaging development from concept through commercialization.

You will define verification/validation strategies for packaging performance, sterility, and distribution robustness, while supporting labeling content, UDI, and global regulatory alignment across product