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- Tasks: Lead R&D for medical devices, focusing on system design and risk engineering.
- Company: Micrel Medical Devices is a global leader in drug delivery systems since 1980.
- Benefits: Enjoy remote work, travel opportunities, and collaboration with international teams.
- Why this job: Join a dynamic team innovating life-saving technology and enhancing patient care.
- Qualifications: 10+ years in medical devices, strong V&V experience, and knowledge of regulations required.
- Other info: Experience with infusion pump systems is 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 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 interviews.
✨Tip Number 2
Highlight your experience in leading cross-functional teams, especially in the context of system engineering and risk management. Be prepared to discuss specific projects where you successfully collaborated with different departments to achieve a common goal.
✨Tip Number 3
Prepare to showcase your problem-solving skills by discussing complex system issues you've encountered in the past. Think of examples where you provided technical leadership and how your decisions positively impacted project outcomes.
✨Tip Number 4
Since this role involves travel to Europe for collaboration, be ready to express your enthusiasm for working in diverse environments. Share any previous experiences you have had with international teams or projects to highlight your adaptability.
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 your experience with regulatory standards and how you can contribute to Micrel's mission.
Highlight Cross-Functional Collaboration: In your application, provide examples of how you've successfully worked with cross-functional teams. This is crucial for the R&D Lead position, so demonstrate your ability to communicate technical concepts effectively.
Showcase Problem-Solving Skills: Include specific instances where you've troubleshot complex systems or led risk mitigation efforts. This will illustrate your analytical skills and suitability for the challenges of the role.
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 this will demonstrate your capability to handle the responsibilities of the R&D Lead role.
✨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 past roles, as this knowledge is crucial for ensuring compliance in the position.
✨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 in the past. Highlight your communication skills and ability to optimise workflows.
✨Prepare for Technical Questions
Expect technical questions related to system engineering, risk management, and troubleshooting complex systems. Brush up on your problem-solving skills and be ready to provide detailed answers or examples that showcase your analytical abilities.
