Team Lead - Design Control, Risk & Usability

Design Control, Risk and Usability Team Lead

Your skills have the power to change lives!

Be part of a leading medical device company dedicated to making tracheotomy care safer and more comfortable for patients worldwide.

If you're passionate about innovation and impact, apply now and make a difference!

Role Incentives

• 30 days of vacation
• Hybrid flexibility
• Company health management program
• Personal and professional development opportunities
• Global, multicultural team
• Exciting summer and winter company events

Your Key Responsibilities

• Oversee design control, risk management, and usability engineering to ensure regulatory compliance
• Ensure continuous alignment between design, risk, and usability processes across internal teams and external partners
• Lead and develop the DCRU Specialist team, managing resources and driving process improvements
• Prepare and present documentation for audits and inspections, ensuring high-quality regulatory compliance

Requirements

• M.Sc. in engineering or a relevant scientific field (e.g., mechanical engineering, medtech, pharmacy, biotechnology)
• 3+ years experience with risk management, design control and usability engineering in medical device development
• In-depth knowledge of ISO 13485, 21 CFR 820.3, ISO 62366, and ISO 14971
• Proven leadership in complex medical device projects from concept to market launch.
• Strong experience managing multicultural, interdisciplinary teams with a focus on MedTech quality standards.
• Experience in design for manufacturing, verification/validation, and process development is a plus
• Fluent in English and German.

Reach out to Vivien Urban for more information about the company culture, and long-term development plans.
 
Who Are Adaptive Life Science?
Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally.
We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.

Why Apply With Us?
Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including:

• Expert advice on your CV and cover letter
• Guidance on salary expectations
• Personalized interview preparation
• Connections to exclusive job opportunities
• Assistance in negotiating the best possible offers
• 50% of the CVs we send to clients are accepted
• Accepted or declined, either way we will provide you with feedback

We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs.
 
Who Do Adaptive Work With?
We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence.
If you are interested in this role, please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.
 
Vivien.urban@adaptivelifescience.com
+49 30 16639819