Key Responsibilities:
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Design and develop sterile barrier packaging systems for medical devices in compliance with regulatory standards.
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Lead packaging validation activities, including:
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Design Verification (DV)
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Shelf-life validation
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Transportation validation (ISTA standards)
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Ensure compliance with ISO 11607, ASTM, and ISTA standards.
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Execute and maintain Design Control documentation as per regulatory requirements.
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Support change control processes for packaging modifications.
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Perform root cause analysis and implement corrective/preventive actions (CAPA).
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Collaborate with cross-functional teams (R&D, manufacturing, quality, and suppliers)
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Engage with external vendors and suppliers for packaging materials and testing.
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Support regulatory submissions and audits (ISO 13485, EU MDR, FDA)
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Contribute to new product development (NPD) and sustaining engineering activities.
Skills and Experience Required:
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Bachelor’s/master’s degree in Packaging Engineering, Mechanical Engineering, or related field.
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7–8 years of experience in medical device packaging (core focus required)
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Strong expertise in:
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Sterile barrier packaging design
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ISO 11607 standards
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ASTM & ISTA testing methods
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Hands-on experience with:
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Design Controls & Documentation
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Packaging validation (DV, PQ, shelf life, transport testing)
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Regulatory compliance (ISO 13485, EU MDR, FDA)
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Strong problem-solving skills with experience in root cause analysis methodologies.
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Experience working with manufacturing and supplier ecosystems.
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Proven ability to handle cross-functional projects and product launches.
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Certification or specialization in packaging engineering will be an added advantage.
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Exposure to global regulatory requirements.
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Prior experience in handling audits and regulatory inspections.
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Strong analytical and technical skill.
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Excellent stakeholder management.
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High attention to detail and compliance-driven mindset.
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Effective communication and collaboration.
Location: Gurugram, Haryana
