Senior Sterilization Engineer (m/f/d)

Senior Sterilization Engineer (m/f/d)

Permanent

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family-owned global technology group we help our customers to always being one step ahead. Whether production, research, sales or administration - we love being the invisible force behind innovation. We deliver world-class quality in the areas of Metals & Recycling, Healthcare, Semiconductor & Electronics and Industrials. As one of the top 10 family-owned companies in Germany, we employ around 16,400 employees in 40 countries. 

About the Role

As a Senior Sterilization Engineer at Medevio, you will play a key role in supporting global development projects and our clients across the full medical device lifecycle. You will collaborate closely with cross-functional teams including Product Development, Operations, Quality, and Regulatory Affairs to ensure sterilization strategies are aligned with project goals and regulatory requirements.

The following challenges await you:

• Lead sterilization activities for Medevio projects and clients worldwide, covering the entire medical device lifecycle.
• Collaborate with internal stakeholders and customers to define sterilization requirements, strategies, timelines, and deliverables.
• Assess sterilization needs for new products, changes, and projects, ensuring robust manufacturing performance and documentation.
• Coordinate with external partners such as sterilization service providers and test laboratories, including sample management, quotation processes, and critical review of protocols and reports.
• Maintain up-to-date knowledge of global medical device regulations, particularly ISO 11135, and apply emerging standards and methodologies in sterilization.
• Ensure implementation of regulatory requirements related to the sterilization of medical devices.

Your profile:

• Bachelor’s or Master’s degree in Engineering (preferably Biomedical, Mechanical), Natural Sciences, Biotechnology or Chemistry.
• Minimum of 5 years of relevant experience in medical device sterilization.
• Strong knowledge of applicable standards and regulations, including ISO 11135, ISO 13485, FDA regulations, and GMP.
• Proven ability to manage and execute multiple projects simultaneously.
• Capable of working both independently and collaboratively with minimal supervision.
• Excellent problem-solving and interpersonal skills; able to communicate effectively across all organizational levels.
• Documented sterilization training by a recognized third party or equivalent internal training by a subject-matter expert.