Packaging Engineer (Medical Devices)

Overview

On Site
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)

Skills

Regulatory Compliance
Project Implementation
Design Documentation
Project Management
Medical Devices
ISO 9000
Risk Management
Creo
SolidWorks
Minitab
Statistics
DMAIC
ROOT
Management
Change Control
Computerized System Validation
Laboratory Equipment
Quality Assurance
Quality Control
QMS
Risk Assessment
Root Cause Analysis
Documentation
Collaboration
Research and Development
Manufacturing
SAFE

Job Details

Role Summary:

We are seeking a hands-on Packaging Engineer to support and lead medical device packaging development projects-focused on spinal implants and surgical instruments. The role involves managing OEM packaging activities and ensuring compliance with FDA, ISO, and MDR (EU) standards, especially for sterile packaging. This is a project-execution-driven role requiring strong cross-functional collaboration, risk management, and design documentation expertise.

Top Required Skills:
  • Sterile Medical Device Packaging Development

  • CAD Tools CREO or SolidWorks

  • Project Management MS Project, DHF documentation, risk mitigation

Must-Have Qualifications:
  • 2+ years of experience in medical device packaging (4 7 preferred)

  • Experience with electrically functional devices is a plus

  • Strong understanding of sterilization methods (EtO, radiation, etc.)

  • Proficiency in FDA/ISO packaging risk management

  • Hands-on with CAD tools (CREO, SolidWorks)

  • Skilled in Minitab/statistical analysis

  • Familiar with DMAIC, 5 Whys, and other root-cause methodologies

  • Proven experience managing cross-functional teams & project timelines

Nice-to-Have Skills:
  • Change control, equipment qualification, CSV

  • Background in packaging/lab equipment commissioning

  • Exposure to QA/QC processes and technical troubleshooting

Key Responsibilities:
  • Design, develop, and validate sterile and non-sterile packaging

  • Create and maintain Design History Files (DHF)

  • Ensure packaging meets regulatory, QMS, and operational requirements

  • Conduct risk assessments, root cause analysis, and documentation

  • Collaborate with R&D, Quality, and Manufacturing to deliver safe, compliant packaging solutions

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

About Intellectt INC