R&D Lead

Micrel Medical Devices SA (www.micrelmed.com), a Medical Technology company with global commercial presence, is looking for an R&D Lead.

Who we are

Micrel 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, Parkinson’s 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 role

We 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 activities
• Analyze system and risk requirements to support system integration and compliance
• Collaborate with cross-functional teams (engineering, quality, regulatory) to optimize workflows and ensure seamless integration
• Enhance Quality Management System (QMS) processes in line with regulatory requirements
• Troubleshoot complex system issues and provide technical leadership for risk mitigation
• Provide guidance on best practices for verification, validation, system engineering and risk management

Qualifications & Experience:      

• 10+ years of experience in medical devices
• Verification & Validation experience including test method validation, planning, execution, and documentation
• Strong background in Systems Engineering (requirement analysis, system integration)
• Experience in Risk Engineering and risk-based decision-making
• Knowledge 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 systems
• Experience working in cross-functional teams and communicating technical concepts effectively
• Experience with infusion pump systems is highly preferred
• Project management skills (PMP or equivalent) are a plus

 Why Join Us?

• Work remotely while contributing to life-saving medical technology
• Collaborate with global teams and travel to Europe for strategic projects
• Be at the forefront of medical device innovation in a growing company