Senior Engineer

3 weeks ago


Bellingham WA, United States KARL STORZ Endoscopy - America Full time

Job Title: Senior Sterilization Process Engineer Karl Storz United States (KSUS) is seeking a dynamic and experienced Senior Sterilization Process Engineer to lead our sterilization processes for Single Sterile Use (SSU) medical devices. You will be instrumental in advancing our SSU products, ensuring they meet the highest regulatory standards and contribute to our core business strategy. At KSUS, you will have the opportunity to lead critical projects that ensure the safety and efficacy of life-saving medical devices. Oversee 510k/PMA design validation, verification testing, and documentation for SSU devices in the US market. Manage relationships with sterilization providers and ensure rigorous release testing protocols. Collaborate cross-functionally with engineering, regulatory, and manufacturing teams on new product designs and process improvements. Represent KSUS 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; In-depth knowledge of CFR regulations pertaining to medical device sterilization and EN ISO 13485 standards. Advanced proficiency in MS Office, particularly Excel for data analytics. Strong analytical and problem-solving skills, with experience in Lean Manufacturing, Six Sigma, and Continuous Improvement principles. Proven project management skills with the ability to manage multiple priorities effectively. At KARL STORZ our 9,000 global associates pride ourselves on harnessing leading technologies, precise workmanship, and dedicated customer support to support the future of medical technology as we pioneer the way forward. We are setting new standards in precision and safety, from improving diagnosis to enhancing outcomes. We see beyond the limits of traditional medicine.



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