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.
Job Tags