Position Overview:
The New Product Introduction (NPI) Engineer is responsible for leading design transfer activities and delivering a portfolio of projects that support and sustain the Infusion Care product range, while aligning with the strategic priorities of the Infusion Care Business Unit.
Key Responsibilities:
Develop processes and specifications for new product development and for improvement of existing processes/products to ensure the delivery of required documentation to allow smooth transition of processes and design from Science & Innovation (S&I) to manufacturing (Design transfer).
Design and develop new materials or improve existing products / materials in accordance with customer requirements and in compliance with current regulatory requirements and standards following valid Standard Operating Procedures (SOPs) from design and Change Control Request (CCR).
Lead team assignments and projects, establish strategies for their work and project execution as needed by the Project Manager or Change Control Request (CCR) owner.
Evaluate requirements of new projects or resources; estimate realistic time to completion.
Prioritize resource deployment in alignment with stakeholders’ priorities and overall business impacts.
Develop clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders.
Ensure all required feasibility work, analysis, validation, testing, and trials are performed on time and to the required Quality and Regulatory standards, as well as in line with Convatec procedures and processes.
Maintain working technical knowledge of a broad range of manufacturing processes and materials areas relevant to the Infusion Care product range.
Ensure project activities (design transfer) are carried out within a Design Controls Framework in accordance with ISO 13485 & 21 CFR 820 Quality Systems.
Develop and maintain strong, collaborative working relationships with all key internal and external organizational stakeholders.
Corrective Actions and Preventive Actions (CAPA) relating to product design, product of packaging design changes to improve quality or reduce cost.
Represent Science and Innovation (S&I) for Infusion Care in the Change Control Request (CCR), NC (Non-Conformity) / Corrective Actions and Preventive Actions (CAPA), and New Product Development (NPD) processes/transfer.
Lead the Design and Development of medical devices from Concept to Launch.
Direct creation of new concepts via 3D models and assemblies in CAD/CAM software (preferably Solidworks and Autocad).
Resolve concept ideas to practice through prototyping and/or other rapid simulation techniques.
Participate in the design and development of new products in accordance with customer request andin compliance with regulatory requirements via SOPs (e.g. Design inputs, Design output, Material/Product specifications, Product drawings, Product Verification and Validation, Test method development, shelf life, biocompatibility, design transfer, design review).
Responsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks.
Participate in risk management meetings supporting the risk mitigations from product design requirements.
Participate in design for manufacturing and design for assembly discussions.
Participate in process development activities (DOE, ES) and support as NPI Engineer on process validations (OQ, PQ).
Create the necessary documentation according to the internal systems (QMS-SAP) to be able to plan a special test run, such as Quality Alert, training, Test Order format, etc.
Plan the activities required with the team (logistics, materials, purchasing, production, planning, shipping, quality, etc) to run properly in production the special test order.
Ensure the successful execution of the test order by being present during production, training the personnel…