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Medical Device Packaging Developer
2 weeks ago
We are seeking a highly skilled Medical Device Packaging Developer to join our team at Capgemini Engineering. As a Medical Device Packaging Developer, you will be responsible for designing and implementing innovative packaging solutions for medical devices. You will work closely with cross-functional teams to deliver compliant and efficient packaging solutions that meet stringent industry standards.
Main Responsibilities:- Packaging Solution Development: Develop and implement packaging solutions for medical devices.
- Cross-Functional Collaboration: Collaborate with internal teams and external suppliers to ensure seamless project execution.
- Documentation and IP Protection: Maintain engineering documentation with detailed packaging specifications and safeguard intellectual property rights.
- Feasibility and Testing: Conduct thorough feasibility studies, material evaluations, and performance testing to ensure packaging solutions meet regulatory requirements.
- Design Specifications: Define performance criteria, select appropriate materials, and create detailed design specifications for packaging products.
- Supplier and Stakeholder Management: Build and maintain strong relationships with suppliers, production, and packaging component stakeholders.
- Project Leadership: Manage project timelines and deliverables, ensuring alignment with stakeholder, external vendor, and organizational goals.
- Regulatory Compliance: Ensure all packaging solutions adhere to relevant regulatory frameworks and standards.
- Process Improvement: Identify areas for continuous improvement in packaging processes and technologies.
- Production Readiness: Supervise production activities, ensuring alignment with design-for-manufacturability (DFM) principles.
Essential Qualifications:
- A Master's Degree in Engineering or a related field is required.
- A minimum of 5 years of total work experience, with at least 2-3 years specifically in packaging development within regulated industries.
- Expertise in product development of paper board-based packaging, from concept to production.
- Strong skills in managing relationships with suppliers, vendors, and third-party stakeholders as well as internal stakeholders.
Tech Requirements:
- Proficient in packaging materials, validation, and testing protocols.
- Knowledge of Quality Management Systems (QMS) ISO 13485:2006 and ISO 11608-1:2022.
Industry Experience:
- Experience in executing projects in regulated environments and compliance guidelines.
- Preferred experience in pharmaceutical or medical device packaging.
- Fluent in English, collaborate effectively across diverse cultural settings & international teams.
