Sterile Single Use Sterilization Engineer
16 hours ago
We are seeking a highly skilled Sterile Single Use Sterilization Engineer to join our team at KARL STORZ Endoscopy - America.
About the RoleThis is a critical position that requires a strong background in sterilization techniques and a proven track record of bringing Single Sterile Use (SSU) devices to market in the US.
Key Responsibilities- Lead the validation and compliance of clean rooms and sterilization processes.
- Oversee 510k/PMA design validation, verification testing, and documentation for SSU devices.
- Manage relationships with sterilization providers and ensure rigorous release testing protocols.
- Collaborate with cross-functional teams on product designs and process improvements.
- Stay updated on sterilization technologies and regulations related to SSU devices.
- Represent KARL STORZ in communications with regulatory bodies such as the FDA, ensuring all products meet federal standards.
- Implement and maintain internal quality systems in alignment with FDA Quality System Regulation, ISO 13485, and ISO 9001.
- Bachelor's degree in Toxicology, Biology, Chemistry, Chemical Engineering, or Material Science; an advanced degree is preferred.
- A minimum of 5 years of experience in various sterilization techniques, with a strong background in bringing SSU devices to market in the US.
- In-depth knowledge of CFR regulations pertaining to medical device sterilization and ISO 13485 standards.
- Proficiency in MS Office, especially Excel; strong data analytic skills.
- Strong analytical and problem-solving skills, with experience in Lean Manufacturing, Six Sigma, and Continuous Improvement principles.
- Proven project management capabilities; ability to manage multiple priorities effectively.
KARL STORZ is an independent, family-owned company headquartered in Germany's renowned MedTech manufacturing region. For 80 years, we've pioneered the most groundbreaking innovations in endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike.
We pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. It's not just about the tools we create—it's about the lives we change, together.
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