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- Tasks: Lead R&D for medical devices, focusing on design, risk engineering, and verification.
- Company: Join Micrel Medical Devices, a global leader in innovative drug delivery systems.
- Benefits: Enjoy remote work flexibility and travel opportunities to Europe for collaboration.
- Why this job: Make a real impact in healthcare while working with cutting-edge technology and diverse teams.
- Qualifications: 10+ years in medical devices, strong V&V experience, and knowledge of regulations required.
- Other info: Project management skills are a plus; infusion pump experience preferred.
The predicted salary is between 43200 - 72000 £ per year.
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
R&D Lead employer: Micrel Medical Devices
Contact Detail:
Micrel Medical Devices Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land R&D Lead
✨Tip Number 1
Familiarise yourself with the specific medical device regulations and standards mentioned in the job description, such as FDA, MDR, and ISO 13485. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during discussions.
✨Tip Number 2
Highlight your experience in leading cross-functional teams, especially in the context of system engineering and risk management. Be prepared to share specific examples of how you've successfully collaborated with different departments to achieve project goals.
✨Tip Number 3
Since this role involves troubleshooting complex systems, think of a few challenging situations you've faced in previous roles. Prepare to discuss your problem-solving approach and the outcomes, as this will showcase your analytical skills.
✨Tip Number 4
Research Micrel Medical Devices and their product offerings, particularly their ambulatory infusion pumps. Understanding their technology and market presence will allow you to tailor your conversations and show genuine interest in contributing to their mission.
We think you need these skills to ace R&D Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical devices, particularly in verification and validation. Emphasise your background in systems engineering and any specific projects related to infusion pump systems.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical technology and your understanding of Micrel Medical Devices' mission. Mention your experience with regulatory standards and how you can contribute to their R&D efforts.
Highlight Cross-Functional Collaboration: In your application, provide examples of how you've successfully worked with cross-functional teams. This is crucial for the role, so demonstrate your ability to communicate technical concepts effectively.
Showcase Problem-Solving Skills: Include specific instances where you've troubleshot complex system issues or led risk mitigation efforts. This will illustrate your analytical skills and suitability for the R&D Lead position.
How to prepare for a job interview at Micrel Medical Devices
✨Showcase Your Experience
Make sure to highlight your 10+ years of experience in medical devices during the interview. Discuss specific projects where you led verification and validation efforts, as well as your background in systems engineering.
✨Understand Regulatory Standards
Familiarise yourself with relevant medical device regulations and standards such as FDA, MDR, ISO 13485, and IEC 62304. Be prepared to discuss how you've applied these standards in your previous roles.
✨Demonstrate Problem-Solving Skills
Prepare examples of complex system issues you've troubleshot in the past. Highlight your analytical skills and how you approached risk management and decision-making in those situations.
✨Emphasise Collaboration
Since the role involves working with cross-functional teams, be ready to share experiences where you successfully collaborated with engineering, quality, and regulatory teams. Show how you can communicate technical concepts effectively.
