Job Title

Micrel Medical Devices SA (www.micrelmed.com), a Medical Technology company with global commercial presence, is looking for an R&D Lead.Who we areMicrel Medical Devices is a dynamic medical technology company designing, manufacturing and marketing drug delivery systems. The company offers a full range of ambulatory infusion pumps and related disposables for a broad array of hospital and home-based patient treatments. 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.The roleWe are seeking an experienced medical device design control R&D lead to drive critical system design, risk engineering and verification for our ambulatory infusion pump system. This is a full-time remote position. Travel to Europe is required for on-site collaboration.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.Key Responsibilities:Lead small teams focused on system & risk engineering and verification and validation activitiesAnalyze system and risk requirements to support system integration and complianceCollaborate with cross-functional teams (engineering, quality, regulatory) to optimize workflows and ensure seamless integrationEnhance Quality Management System (QMS) processes in line with regulatory requirementsTroubleshoot complex system issues and provide technical leadership for risk mitigationProvide guidance on best practices for verification, validation, system engineering and risk managementQualifications & Experience:10+ years of experience in medical devicesVerification & Validation experience including test method validation, planning, execution, and documentationStrong background in Systems Engineering (requirement analysis, system integration)Experience in Risk Engineering and risk-based decision-makingKnowledge of medical device regulations and standards (FDA, MDR, ISO 13485, 14971, IEC 61010, IEC 62304, IEC 81001)Strong analytical and problem-solving skills with the ability to troubleshoot complex systemsExperience working in cross-functional teams and communicating technical concepts effectivelyExperience with infusion pump systems is highly preferredProject management skills (PMP or equivalent) are a plusWhy Join Us?Work remotely while contributing to life-saving medical technologyCollaborate with global teams and travel to Europe for strategic projectsBe at the forefront of medical device innovation in a growing company