Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to ForeverCaring as a Engineer II – Research and Development and you’ll do the same. The Engineer II – Research and Development provides both New and Existing Product Development support, remediation activities performance, participates in Material change and Base Business projects relating to Accessories and 3rd Party manufactured products. This position focuses on development of design documentation and test-methods to verify the Product compliance with international standards and established company procedure. Key Responsibilities: • Design and development of new or improvement of existing products, systems, and process components. • Development of process specifications for new products and improved processes/products, ensuring the accurate completion of the required documentation to ensure transition of processes and design from R&D to manufacturing • Preparation of prototyping lines and prototypes of product • To perform laboratory tests at site in cooperation with Quality Management • To ensure that design documentation is prepared according to required standards and established company procedures • To Perform good and seamless communication, Global T&I, Global Marketing, Global and local Quality, Regulatory and Clinical as well as functions in Global and Local Manufacturing and Supply Chain • To participate in Risk Assessments • To update / create drawings in cooperation with Global R&D Engineering • To create specification of products, raw materials, semi-finished goods etc. • To develop test methods • To perform the Design review of drawings / measurement / test methods etc. • To initiate and perform shelf-life testing • To initiate and perform biocompatibility testing (external contracting) • To determine effects of (re)-sterilization • To ensure compliance with the legislative and internal requirements of the EHS and to participate in the fulfillment of the companys targets in the EHS area For Existing Product remediation purpose: • To develop Product design Inputs/Outputs • To perform Product design verification • To perform Product design validation • To perform Final Design Review • To perform any other duties assigned by the immediate superior Authority: • R&D Approver / technical Approver • R&D Owner Change Control Record (CCR´s and ECCF’s) Skills & Experience: • Good analytical skills and technical knowledge in product development and especial in design, materials and processes • Proficien in compuer systems such as Microsoft office, Microsoft Excel, Minitab (or equivalent) and Solidworks (AutoCAD) • Ability to communicate effectively in English • Able to work independently though still be a team player • Able to work cooperatively with other departments to achieve results Desirable but not required: • Experience within product / process development. • Experience in Product and/or process development in a highly regulated area such as Medical products, Pharmaceuticals, Food Qualifications/Education: • Bachelor of science in Engineering, Plastic, Mechanical or related field • Analytical mind, technical and communicative skills • Self-development through continuous learning and knowledge sharing • General PC experience and specific experience in spreadsheets • Statistical know-how and beneficial if experience into Statistics programs Preferred training requirements: • Introduction training for administrative employees • Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required • Quality System documents and procedures relevant to job performance Principal Contacts & Purpose of Contact • Internal – Global T&I, Global Marketing, Global Quality, Global Supply, Advanced operations - general daily projects related communication • External – 3rd Party Suppliers of Accessory products – project specific communication Travel Requirements • Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected.(variable and project related) Most trips will include overnight travel