Packaging Engineer
7 days ago
Position: Packaging Engineer – Medical Devices
Overview:
Seeking a Packaging Engineer to design and develop sterile and non-sterile packaging for spinal implants and instruments. The role involves managing OEM packaging projects, maintaining Design History Files, and ensuring compliance with FDA and ISO standards.
Key Responsibilities:
- Design, develop, and test medical device packaging for protection, handling, and compliance.
- Create and manage documentation per GMP and QMS requirements.
- Lead cross-functional teams to drive project execution on time and within scope.
- Apply scientific problem-solving (DMAIC, risk management) and process validation methods.
- Utilize CAD tools (CREO/SolidWorks) and statistical software (Minitab).
Must Have:
- 2–7 years in medical device design, development, and manufacturing.
- Experience in sterile packaging (ethylene oxide, radiation, etc.).
- Strong project management, problem-solving, and communication skills.
- Knowledge of FDA/ISO standards and risk management.
Nice to Have:
- Change control, equipment qualification, and process validation experience.
- Six Sigma or DFSS certification.
Top Skills: CREO, Sterile Packaging Development, Project Management
Job Type: Contract
Pay: $ $40.00 per hour
Benefits:
- Health insurance
Work Location: In person
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