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For Companies At a Glance
- Tasks: Lead R&D efforts for medical device design and verification.
- Company: Join Micrel Medical Devices, a global leader in drug delivery systems.
- Benefits: Enjoy remote work flexibility and travel opportunities to Europe.
- Why this job: Make a real impact in life-saving technology while innovating in a dynamic environment.
- Qualifications: 10+ years in medical devices with strong V&V and systems engineering experience required.
- Other info: Experience with infusion pump systems is highly preferred; project management skills are a plus.
The predicted salary is between 48000 - 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 latest medical device regulations and standards, especially those mentioned in the job description like 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
Network with professionals in the medical device industry, particularly those who have experience with infusion pump systems. Engaging in conversations with them can provide insights into the challenges and innovations in the field, which you can reference in your discussions.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences that showcase your skills in verification and validation, as well as risk engineering. Highlighting your problem-solving abilities in complex system integration scenarios will set you apart.
✨Tip Number 4
Since this role involves collaboration with cross-functional teams, think about how you can effectively communicate technical concepts to non-technical stakeholders. Being able to bridge that gap will be a valuable asset in your discussions.
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 the role. Mention specific experiences that align with the responsibilities outlined in the job description, such as leading teams or enhancing quality management processes.
Highlight Regulatory Knowledge: In your application, clearly demonstrate your knowledge of medical device regulations and standards. Mention any direct experience you have with FDA, MDR, ISO 13485, or other relevant standards to show you are well-versed in compliance.
Showcase Problem-Solving Skills: Provide examples in your application that illustrate your strong analytical and problem-solving skills. Discuss specific challenges you've faced in previous roles and how you successfully resolved them, particularly in complex system integration.
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 role in system engineering and risk management.
✨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, as this will demonstrate your expertise in compliance.
✨Emphasise Cross-Functional Collaboration
Since the role involves working with cross-functional teams, be ready to share examples of how you've successfully collaborated with engineering, quality, and regulatory teams. Highlight any challenges you faced and how you overcame them to ensure seamless integration.
✨Prepare for Technical Questions
Expect technical questions related to system design, risk engineering, and troubleshooting complex systems. Brush up on your problem-solving skills and be ready to discuss specific methodologies or tools you’ve used in past projects.
