Sterilization Subject Matter Expert (m/f/d)

Heraeus; Dresden; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Heraeus is seeking a Senior Sterilization Engineer to support global development projects and ensure sterilization strategies align with regulatory requirements. You'll work closely with cross-functional teams and manage sterilization activities throughout the medical device lifecycle, leveraging your expertise in standards and regulations to ensure compliance and effective product delivery.

Qualifikationen

• 5+ years relevant experience in medical device sterilization.
• Knowledge of ISO 11135, ISO 13485, FDA regulations, and GMP standards.

Aufgaben

• Lead sterilization activities for projects and clients worldwide.
• Collaborate to define sterilization requirements, strategies, and deliverables.
• Ensure implementation of regulatory requirements for sterilization.

Kenntnisse

Project Management

Problem-Solving

Interpersonal Skills

Ausbildung

Bachelor’s or Master’s degree in Engineering

Documented sterilization training

Jobbeschreibung

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.

Curious? Apply now!

We look forward to receiving your documents by reference code 58107 via our online application portal.

Any further questions?

Our Recruiting Team, Heraeus Medevio, is happy to assist you by email: [e-mail]. Or visit us at jobs.heraeus.com.