Medical Device Packaging Engineer — Onsite (Hoover)

Gd Energy Products, Llc; Hoover (AL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical plans

FSA / HSA

Vision benefits

Dental insurance (employee & depend.)

Wellness plan

401k with 5% match

PTO with holidays

Short/Long disability

Life insurance

Parental leave

Casual dress code

Social events

Job summary

BioHorizons, a Henry Schein company in Hoover, AL, is seeking a Packaging Engineer onsite to lead packaging and labeling design, development, and lifecycle management for medical devices, ensuring compliance with FDA 21 CFR Part 820, EU MDR, ISO and company procedures.

You will collaborate across Manufacturing, QA, Regulatory Affairs, Brand, Operations and suppliers to support design transfer, qualification (IQ/OQ/PQ), and continuous improvement.

Qualifications

• High proficiency in MS Office Suite required.
• High proficiency in device labeling software required.
• Proficiency in CAD design software (e.g. SolidWorks) required.
• Experience with U.S. FDA, EU MDR and ISO requirements for design controls of medical devices required.
• Demonstrated ability to engage effectively and professionally with internal stakeholders and external customers across all levels of the organization
• Overnight travel may be necessary.

Responsibilities

• Contribute to packaging and labeling activities in alignment with U.S. FDA, EU MDR, and other applicable global regulatory requirements.
• Develop packaging concepts and solutions based on product design inputs, user needs, and manufacturing requirements.
• Create and maintain packaging and labeling specifications, and support prototype development, design verification, and validation activities.
• Develop and maintain technical documentation including packaging drawings, manufacturing routers, and bills of materials.
• Develop and maintain market-specific labeling content, including labels, packaging graphics, and Instructions for Use, in accordance with applicable regulatory and business requirements.
• Support the qualification of packaging and labeling equipment and software through participation in installation, operational, and performance qualification activities (IQ, OQ and PQ).
• Contributes to the development and optimization of in-house and outsourced packaging and labeling processes to improve efficiency, consistency, and scalability.
• Develop and maintain procedures and work instructions related to packaging, labeling, and production support activities.
• Evaluate packaging technologies, materials, and industry trends to support continuous improvement and innovation.
• Support risk management activities for packaging and labeling systems, including participation in documentation such as failure mode and effects analyses.
• Collaborate with production teams, automation engineers, and cross-functional stakeholders to support implementation and ongoing improvement of packaging and labeling solutions.
• Partner with Manufacturing, Quality Assurance, Regulatory Affairs, Brand Management, Operations, and external suppliers to execute assigned projects and support product lifecycle needs.
• Complete assessments of state-of-the-art standards and guidance documents related to packaging and labeling, including recommendations for due diligence.

Skills

MS Office Suite

Labeling software

FDA/Regulatory knowledge

Stakeholder engagement

Overnight travel willingness

Education

Bachelor's degree in Engineering (Mechanical or Biomedical preferred)

Tools

SolidWorks

CAD design software

Job description

BioHorizons, a Henry Schein company in Hoover, AL, is seeking a Packaging Engineer onsite to lead packaging and labeling design, development, and lifecycle management for medical devices, ensuring compliance with FDA 21 CFR Part 820, EU MDR, ISO and company procedures.

You will collaborate across Manufacturing, QA, Regulatory Affairs, Brand, Operations and suppliers to support design transfer, qualification (IQ/OQ/PQ), and continuous improvement.