Job Summary
Key Responsibilities
2. To lead a team of designers, provide guidance, and ensuring the delivery of high-quality design solutions in alignment with the overall business goals.
3. To present design concepts and strategies to stakeholders and gather feedback.
4. To establish and maintain design standards, guidelines, and best practices.
5. To stay abreast of industry trends, emerging technologies to drive innovation and excellence in design.
Skill Requirements
Packaging Technical Leadership & Project Execution
• Lead packaging engineering activities for new products, line extensions, and sustaining programs, ensuring alignment with project timelines, cost, quality, and regulatory requirements.
• Provide technical leadership in packaging concept development, material selection, design inputs, and validation strategies.
• Serve as a key technical contributor and subject matter expert for packaging technologies, materials, methods, and processes within cross functional project teams.
• Drive packaging deliverables through all phases of the product lifecycle, from concept through commercialization and sustaining support.
• Ensure cross-functional strategies are clearly communicated and risks are appropriately managed.
Packaging Design & Development
• Design and develop primary, secondary, and tertiary packaging solutions for sterile and non sterile medical devices.
• Lead packaging feasibility studies, risk assessments, and design for manufacturability evaluations.
• Develop prototype packaging, and coordinate tooling and equipment needs to support development and testing.
• Manage packaging related changes for sustaining products, including component, supplier, and process changes.
• Prepare packaging cost estimates as required. Experienced developing PFMEA and DFMEA.
Testing, Qualification & Validation
• Develop and execute packaging test plans, including transit testing, shelf life studies, environmental conditioning, and performance evaluations.
• Lead qualification and validation of packaging components, equipment, processes, and operations in compliance with FDA, ISO, ASTM, and EU MDR requirements.
• Analyze test data and independently author technical reports, validation summaries, and documentation to support regulatory submissions, product launches, and design changes.
• Troubleshoot packaging performance and manufacturing issues using structured problem solving methodologies and corrective action approaches.
• Owner of packaging specifications, responsible for the definition of all packaging system specifications.
• Collaborates in the design control process for high complexity projects.
• Collaborates on complex projects impacting design inputs/outputs and verification through testing and analysis from start to finish.
Commercialization & Manufacturing Transfer
• Plan and coordinate all packaging engineering activities to support product launch and transfer to manufacturing, including development and execution of packaging transfer plans.
• Coordinate packaging documentation release, test protocols, reports, and design control documentation.
• Support planning, ordering, and coordination of new packaging component inventory to meet launch and production needs.
• Participate in packaging line trials, equipment evaluations, and process qualifications during scale up.
Cross Functional, Supplier Support
• Demonstrated success collaborating with cross-functional projects involving new product development, sustaining engineering, and cost optimization initiatives.
• Work with suppliers, vendors, and contract manufacturers to develop, optimize, qualify, and maintain packaging components and materials.
• Provide technical support for design reviews related to packaging.