Packaging Developer (m/f/d)

Development of innovative packaging solutions for sterile medical devices – taking into account all relevant regulatory requirements (EU 2017/745, ISO 11607, ISO 13485) and focusing on functionality, safety and quality. Planning, implementation and evaluation of production experiments in close cooperation with the fields of production, process technology and quality assurance. Coordination and support of customer tests – from conception to outcome presentation – in direct coordination with our customers. Planning and implementation of laboratory analyses, including laboratory personnel guidance and control and supervision of external test laboratories. Technical support for production in coating processes and bag production as well as in internal process validations. Advising our customers: inside packaging processes and packaging validations – competent, solution-oriented and practical. Close cooperation with Regulatory Affairs and Quality Management to ensure continuous product compliance. Conducting risk analyses and creating sound risk assessments in German and English. Coordination and implementation of change processes in compliance with the requirements of the quality management system (ISO 13485) and risk management (ISO 14971). Proactive development of new concepts and materials for sustainable, pioneering packaging solutions in the medical sector. Self-maintaining and expanding contacts to suppliers, customers and other external partners in the field of sterile packaging. Integration of new regulatory or customer-specific requirements in coordination with regulatory, quality management, quality assurance, production and sales. Preparation and presentation of analytical results and preparation of technical reports for management, internal specialist departments and customers.

You have a successfully completed scientific or technical study – ideally focusing on packaging technology, engineering and medical technology. A master's degree or equivalent qualification is preferred; at a bachelor's degree you additionally convince by a qualified further subject. On your professional path you have already gained several years of experience – be it in handling flexible packaging materials such as plastic films and paper or in the demanding regulatory environment of sterile medical packaging. You have developed a safe feel for quality, precision and the special requirements of sensitive products. The creation of sound, sophisticated documentation and reports – both in German and English – is part of your repertoire as well as the structured planning, control and documentation of projects. You understand that complex content is clearly formulated and projects are targeted at success. In dealing with statistical methods for experimental planning and evaluation, you act confidently and use modern software solutions to make informed decisions. Their analytical thinking combined with organisational skill, self-initiative and pronounced communication strength. You are characterised by a conscientious, structured and targeted way of working and always keep an overview even in demanding tasks. Your independence is just as natural for you as a high degree of sense of responsibility. Your very good knowledge of German and English in word and writing will certainly be used in the international context. In addition, you have excellent knowledge in common MS Office applications, especially in Excel, Word and Outlook. You combine technical understanding with regulatory know-how and are confident in the field of tension between innovation and norm conformity. Knowledge of risk management for medical devices (ISO 14973) and quality management according to ISO 13485 perfectly complete your profile.

A challenging and versatile task with the chance to bring your skills into a successful family business with tradition An exciting and responsible role with a high degree of self-responsibility in a growing company A pleasant working environment, characterized by flat hierarchies, with short decision paths and collegial cooperation between all areas of our company A targeted and comprehensive incorporation is of course for us Individual development opportunities and training opportunities An attractive remuneration that honors your services Occupational pensions and benefits Cycling leasing Air-conditioned office rooms, a high-quality IT equipment (handy, laptop etc.) as well as a canteen with a varied range is of course for us Your future workplace is conveniently located and offers free parking on the premises