Sr R&D Chemist - Solutions for Dialysis - Renal Care

Sr R&D Chemist or Chemical Engineer BELLCO, now part of Medtronic in the Renal Care business, is a company, based in Mirandola (Modena – ITALY), leader in systems for hemodialysis and extracorporeal blood purification. Our therapies and systems are employed for the treatment of renal failure, multiple organ failure, sepsis and cardiac decompensation. We are focused on satisfying the needs of patients and experts through: Innovation, Reasearch, Development of advanced Nephrology, Intensive Care and Cardiology Therapies. Job responsibilities Candidate will be in charge of Research and Development of: - New and improved chemical products within dialysis scope (either medical devices either pharmaceuticals), moving from requirements till release of the product, working with other R&D lines to integrate the product in the system and other company functions like Quality and Manufacturing to guarantee that requirements of every phase of the value chain are met - New and improved chemical plant equipment and processes for manufacturing chemical products: to provide requirements and specifications for and to support manufacturing engineering function in developing and sustaining manufacturing plant and processes to meet requirements on products. Education: Master degree in Chemistry, Chemical Engineering or Pharmaceutical Technologies Languages: Italian and English Professional experiences Mandatory – at least 5 years’ experience in - development of Chemical solutions - development/knowledge of Chemical products manufacturing process - development/knowledge of Chemical plants Recommended - development of Medical devices/pharmaceuticals - development/knowledge of dialysis concentrate solutions (for chronic, acute, peritoneal treatments) Specific and nice to have knowledges - European Pharmacopea (Ph.Eur.) and United States Pharmacopeia (USP) for Solutions for peritoneal Dialysis, Hemofiltration and hemodiafiltration, hemodialysis solutions - ISO 14971:2019 ‘Medical devices — Application of risk management to medical devices’ - ISO 13485:2016 ‘Medical devices - Quality management systems - Requirements for regulatory purposes’ - principles and guidelines of Good Manufacturing Practices (GMP); - Medical Device Directive (93/42/EEC) and Medical Device Regulation (Regulation (EU) 2017/745); - IEC 60601-2-16 - IEC 60601-2-39 ...