Job Description

Job Title: Packaging Validation Engineer – Seal Integrity

Department: Core Medical Device – Packaging Engineering

Location: Bay Area, CA

Job Summary:

We are seeking a detail-oriented and experienced Packaging Validation Engineer to join our Core Medical Device team. This role is critical to ensuring the integrity, reliability, and regulatory compliance of sterile barrier systems, with a key focus on seal integrity validation. The ideal candidate will have hands-on experience with ISTA and ASTM standards , and a solid understanding of medical device packaging lifecycle and regulatory requirements.

Key Responsibilities:

• Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems.
• Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards.
• Design and perform package performance and distribution testing , including drop, vibration, and compression tests.
• Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies.
• Drive root cause analysis and CAPA related to packaging failures.
• Maintain compliance with applicable regulatory standards including ISO 11607 , FDA 21 CFR 820 , and related guidelines.
• Manage packaging documentation including DHF, DMR, and validation records.
• Support continuous improvement initiatives in packaging processes and materials.
• Interface with external testing labs and suppliers to coordinate validation activities.

Required Qualifications:

• Bachelor’s degree in Packaging Engineering , Mechanical Engineering , Biomedical Engineering , or a related technical field.
• 3–6 years of experience in medical device packaging , with a strong emphasis on validation and seal integrity testing .
• In-depth knowledge of ISTA and ASTM test standards (e.g., ASTM F88, F1929, D4169).
• Familiarity with ISO 11607 and other global packaging regulations.
• Proficient in developing test protocols, analyzing data, and writing technical reports.
• Strong analytical skills and problem-solving abilities.
• Experience working in a regulated environment (FDA, ISO).
• Excellent communication and cross-functional collaboration skills.

Preferred Qualifications:

• Advanced degree (MS) in a relevant field.
• Experience with packaging equipment validation (IQ/OQ/PQ) .
• Knowledge of statistical tools and software (e.g., Minitab, JMP).
• Understanding of sterilization methods (EtO, gamma, etc.) and how they impact packaging materials.

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