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Senior Sterilization Process Engineer
2 months ago
Job Title: Senior Sterilization Process Engineer
About the Role:
KARL STORZ Endoscopy - America is seeking a highly skilled and experienced Senior Sterilization Process Engineer to lead our sterilization processes for Single Sterilization Use (SSU) medical devices.
Key Responsibilities:
- 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 KARL STORZ Endoscopy - America 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.
Requirements:
- 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.
About Us:
KARL STORZ Endoscopy - America is a leading manufacturer of endoscopic and medical imaging equipment. Our company is committed to delivering high-quality products and services that meet the needs of our customers.
What We Offer:
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Language: English (en-US)
