Requirements: English
Company: Micrel Medical Devices
Region: france, fr ,
Micrel Medical Devices SA ( a Medical Technology company with global commercial presence, is looking for an RD Lead. Micrel Medical Devices is a dynamic medical technology company designing, manufacturing and marketing drug delivery systems. Micrel is active in the areas of Pain Management and Analgesia, Parenteral Nutrition, Immunoglobulin Therapy, Parkinsons disease, Thalassemia, Primary Pulmonary Hypertension (PPH) and other infusion therapies. Founded in 1980, Micrel has established a large international distribution network as well as direct subsidiaries in Germany, France, Sweden and Denmark and is currently exporting its products in more than 50 countries around the world. We are seeking an experienced medical device design control RD lead to drive critical system design, risk engineering and verification for our ambulatory infusion pump system. This is a full-time remote position. In this role, you will help lead verification validation efforts, ensuring our medical devices meet the highest regulatory and quality standards. You will work with cross-functional teams to analyze system requirements, develop test plans, improve quality management processes, and troubleshoot complex system integration challenges. Lead small teams focused on system risk engineering and verification and validation activities Enhance Quality Management System (QMS) processes in line with regulatory requirements Provide guidance on best practices for verification, validation, system engineering and risk management 10+ years of experience in medical devices ~ Verification Validation experience including test method validation, planning, execution, and documentation ~ Knowledge of medical device regulations and standards (FDA, MDR, ISO 13485, 14971, IEC 61010, IEC 62304, IEC 81001)~ Project management skills (PMP or equivalent) are a plus Work remotely while contributing to life-saving medical technology Be at the forefront of medical device innovation in a growing company