
Regulated Packaging Engineer
6 days ago
Capgemini Engineering is seeking a highly skilled Regulated Packaging Engineer to develop and implement packaging solutions for the medical device industry.
In this role, you will collaborate with cross-functional teams to design, validate, and deliver compliant packaging solutions that meet stringent standards. Our clients are global leaders in healthcare, known for their advancements in treatments and medical technologies.
Key Responsibilities:- Lead Packaging Development: Develop and implement packaging solutions for medical devices, ensuring compliance with regulations.
- Cross-Functional Collaboration: Work closely with internal teams, external suppliers, and production stakeholders to achieve business objectives.
- Documentation & IP Protection: Maintain accurate and detailed engineering documentation, ensuring the safeguarding of intellectual property rights.
- Feasibility and Testing: Conduct thorough feasibility studies, material evaluations, and performance testing to ensure packaging solutions meet requirements.
- Design Specifications: Develop and maintain design specifications for packaging products, ensuring compliance with regulatory standards.
- Supplier and Stakeholder Management: Establish and maintain strong relationships with suppliers, vendors, and third-party stakeholders to ensure successful collaborations.
- Project Leadership: Lead project teams, manage project timelines, and deliverables, ensuring alignment with stakeholder goals.
- Regulatory Compliance: Ensure all packaging solutions adhere to relevant regulatory frameworks and standards, minimizing risks and ensuring business success.
- Process Improvement: Continuously identify areas for improvement in packaging processes and technologies, implementing changes to enhance efficiency and effectiveness.
- Production Readiness: Ensure production activities align with design-for-manufacturability principles, optimizing packaging solutions for production.
- Master's Degree in Engineering or a related field.
- A minimum of 5 years of total work experience, with at least 2-3 years specifically in packaging development within regulated industries.
- Product Development: Proven expertise in product development of paper board-based packaging, from concept to production.
- Cross-functional (internal) & Supplier Management: Strong skills in managing relationships with suppliers, vendors, and third-party stakeholders as well as internal stakeholders.
- Proficient in packaging materials, validation, and testing protocols.
- Knowledge of Quality Management Systems (QMS) ISO 13485:2006 and ISO 11608-1:2022.
- 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.
- Depending on assignment the position can be hybrid, with flexibility between on-site work and remote collaboration.
- Willingness and flexibility to travel as needed.
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