Role Overview

As a Senior Laboratory Specialist in Cleaning, Disinfection, and Sterilization, you will play a crucial role in supporting our customers in healthcare facilities. The ideal candidate will collaborate closely with the Director of CDS to ensure compliance of our products with existing regulatory requirements in the United States. You will be responsible for supporting testing and documentation requirements for design verification and submissions of 510k for Class II and PMA for Class III devices. Additionally, you will oversee the planning and execution of risk analysis, root cause analysis, and efficacy analyses relevant to and supporting 510k/PMA devices. This role requires a systemic thinker, capable of seeing the big picture and distilling relevant facts.

KeyResponsibilities

• Provide expert guidance to healthcare professionals on cleaning, disinfection, and sterilization processes, including best practices, regulatory compliance, and the use of our products.
• Utilize scientific methods to draw fact-based conclusions during testing for design verification or for troubleshooting and problem solving.
• Collaborate with the director CDS to ensure the accuracy and timeliness of documentation and test data ensuring compliance to 510k/PMA requirements.
• Successfully executes department goals set in collaboration with the director.
• Oversees and coordinates testing activities performed internally or by external labs.
• Provide support for both sustaining and new product development projects.

• Travel: 5-10%, including visits to other KARL STORZ locations, trade shows/congresses, customer sites.

Key Requirements

• Bachelor's degree in healthcare science or related field, or Registered Nurse with a current license in good standing

• Minimum of 5 years of relevant experience in healthcare profession; nursing experience will also be considered.

• Minimum of 2 (two) years' experience with medical device reprocessing
• Strong collaboration skills with the ability to consider various viewpoints and create effective solutions to address issues or concerns.
• Strong attention to detail
• Excellent proficiency with Microsoft products, particularly Word, Excel, PowerPoint. Advanced Excel skills for data analytics required, as well as advanced Word skills for documentation requirements.
• Previous medical device or regulatory experience is desired.
• Previous experience in infection control is desired.

#LI-BL1