Design Control, Risk and Usability Specialist

Adaptive Business Group; Frankfurt; Hybrid; EUR 55.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in medical technology seeks a Design Control, Risk and Usability Specialist to develop innovative medical devices. This role offers hybrid flexibility, 30 days of vacation, and opportunities for personal and professional development. Join a global team and make a real impact in patient care.

Leistungen

30 days of vacation

Hybrid flexibility

Company health management program

Personal and professional development opportunities

Exciting summer and winter company events

Qualifikationen

• 1+ years of experience in Design Control and validation.
• Knowledge of relevant ISO standards.

Aufgaben

• Manage Design Control, Usability Engineering, and Risk Management processes.
• Lead risk management and usability engineering activities.

Kenntnisse

Problem Solving

Quality Mindset

English

German

Ausbildung

Degree in a relevant scientific or technical field

Tools

ISO 13485

21 CFR 820.3

ISO 62366

ISO 14971

Jobbeschreibung

Design Control, Risk and Usability Specialist

Do you want your work to have a real impact?

Use your expertise to develop innovative, life-enhancing medical devices for tracheotomy patients.

Join a global leader in medical technology and help shape the future of patient care. Apply now!

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

• Manage Design Control, Usability Engineering, and Risk Management processes in medical device development from project initiation to submission
• Lead risk management (e.g., FMEAs) and usability engineering activities with project teams
• Ensure high-quality, consistent and conforming DCRU documentation across projects

Requirements

• Degree in a relevant scientific or technical field (e.g., engineering, medtech, pharmacy, biotechnology)
• 1+ years of experience in Design Control and validation, Risk Management and Usability process development in MedTech / Pharma.
• Knowledge of ISO 13485, 21 CFR 820.3, ISO 62366, and ISO 14971.
• Strong quality mindset and problem-solving skills in a regulated environment
• English required, German is a plus

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.