Senior Packaging Engineer
Job in
Washington, District of Columbia, 20022, USA
Listed on 2026-06-27
Listing for:
Medix™
Full Time
position Listed on 2026-06-27
Job specializations:
-
Engineering
Packaging Engineer, Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
- Lead packaging engineering activities for sterile and non-sterile medical devices throughout the product lifecycle.
- Develop, execute, and maintain packaging design verification and validation activities.
- Author and review packaging validation protocols and reports, including IQ, OQ, and PQ studies.
- Develop and execute transportation/shipping validation protocols and testing.
- Author and manage accelerated and real-time aging studies and associated documentation.
- Ensure compliance with ISO 11607 and applicable medical device packaging standards and regulations.
- Support design control activities, risk assessments, design changes, and product development projects.
- Collaborate with contract manufacturers, packaging suppliers, material vendors, and testing laboratories to develop and qualify packaging solutions.
- Evaluate packaging materials, specifications, and manufacturing processes to ensure product protection and regulatory compliance.
- Troubleshoot packaging-related issues and implement corrective actions when necessary.
- Contribute to the establishment and continuous improvement of packaging engineering processes, procedures, and documentation.
- Partner with Quality, Regulatory Affairs, Operations, Supply Chain, and R&D teams to support product launches and ongoing commercial products.
- Bachelor's degree in Packaging Engineering, Engineering, Science, or related technical field.
- Minimum 4 years of medical device packaging engineering experience.
- Direct experience supporting Class I, II, and/or III medical devices.
- Experience with sterile and/or non-sterile packaging systems.
- Strong background in packaging design verification and validation.
- Hands‑on experience developing and executing IQ, OQ, and PQ validation protocols.
- Experience authoring shipping and transportation validation protocols and reports.
- Experience developing and executing accelerated aging and shelf‑life studies.
- Working knowledge of ISO 11607 requirements.
- Experience supporting design control processes and product development activities.
- Strong technical writing and documentation skills.
Position Requirements
10+ Years
work experience
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