Mgr, Containers

Essential Duties and Responsibilities:

• Functional management of team – Hiring, competency building, training, setting SMART goals, ACE Check-ins, providing regular feedback, performance management, development planning, career coaching, budget planning & tracking.
• Responsible for handling team working closely with PDO Organization, Project Management, Regulatory, Quality and the other cross-functions on Renal Care Projects related to product design change and new product registration in compliance with current international/regional/national regulations.
• Responsible for identifying necessary resources and building appropriate teams in to support product development and lifecycle management.
• Expected to develop, document, test and manage product related changes in accordance with established Renal Care product processes and stay in alignment with QMS.
• Responsible for identifying outsourcing partners for product development and lifecycle management related activities as necessary.
• Develop culture of innovation
• Responsible for identifying areas for product enhancements.
• Establish culture within team to create, maintain and update technical & design documentation according to Good Documentation Practices.

Qualifications:

• Postgraduate in Polymer Science and technology with 15 years of experience in polymer material development and design, including technical leadership.
• Prior experience in the Renal Polymers domain is a plus.
• Min 5+ years of relevant experience in medical device and/or drug R&D.
• Good knowledge of Renal PD therapies and products.
• Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service etc.
• Good knowledge of Design Control documentation and process.
• Working knowledge of international/regional/national regulations and standards.