R&D Engineer

Infusion Care R&D Engineer responsible for Customer Projects, New Product Development, and Life Cycle Management of Infusion Care products.,

• Design and development of new products, components and materials following SOPs for Design Control, in compliance with regulatory demands.
• Perform changes on existing products, components and materials following SOPs for Change Control, in compliance with regulatory demands.
• Authors, updates, reviews and approves documents associated with Design Control and Risk Management for R&D.
• Develops and qualifies new test methods for Design Verification and Process Validation.
• Participates in CAPA and NC investigations and provides technical assessment for design related issues.
• Owns root cause investigations associated with product design and the implementation of corrective or preventive actions.
• Collaborates across the organisation and supports colleagues to achieve shared goals and objectives globally.
• Clearly communicates technical data cross-functionally, making proposals and recommendations based on analysis of this data.
• Proactively engages with key stakeholders to manage expectations and delivers on project commitments.
• Maintains expertise by keeping updated on engineering advancements through publications, patents, university/industrial contacts and vendor discussions.
• Identifies and generates new Intellectual Property (IP) and evaluates the existing IP landscape.
• Generates concepts and creates and updates 2D/3D models, assemblies and engineering drawings in CAD software (SolidWorks).
• Considers Design for Manufacturing and Design for Assembly methodologies to develop robust designs, suitable for manufacturing processes.
• Maintains compliance with the QMS and completes all required training on time.
• Maintains compliance with Health, Safety, and Environment standards.
• Follows all Convatec values and behaviours.
Authority (if applicable):
• Review and approval/rejection of all documents where R&D involvement is needed and where a higher level of authority is not required.
• Make decisions for product design, development and design changes.
• Make recommendations for appropriate action in case of product design related issues., Internal - R&D Engineers, Senior R&D Engineers, Senior Managers R&D, Project Managers, and other Core Team members (e.g. Advanced Operations, Artwork and Labelling, Regulatory, Design Assurance etc.) to execute projects and resolve product and process related issues.
External - Suppliers and Test Houses to obtain and provide relevant information to execute projects and resolve product and process related issues. Customers to provide status updates on ongoing projects. Travel Requirements Position may involve travel up to 10% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel.


• Ability to effectively manage and prioritise multiple project workloads, working simultaneously across numerous diverse project teams is essential.
• Demonstratable experience in an engineering discipline with knowledge of Systems and/or Mechanical/Design Engineering is essential.
• Ability to use CAD software packages, preferably experience with SolidWorks is desirable.
• Working understanding of ISO 13485 and 14971 standards, and FDA 21CFR820 is desirable.
• Experience of R&D in the Medical Devices industry and Design Control is desirable.
• Experience performing Root Cause Analysis (RCA) and utilising RCA tools e.g. 5 Why, Ishikawa Diagrams, FMEA is desirable.
• Comfortable working remotely with general supervision.
• Ability to communicate effectively in English (verbal and written) is essential., Qualified to degree level in a relevant STEM related subject, preferably Systems, Mechanical or Design Engineering., Speaking: Yes English
• Writing/Reading: Yes English
  
  At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life.