Overview In this role you contribute to validating and qualifying external devices for reprocessing in ASP sterilization systems, helping shape safe, compliant products. You work within the Technical Business Solutions Team to design experiments, document results, and support technology development from feasibility to verification. You operate under regulated guidelines (FDA, ISO, etc.) and communicate findings to stakeholders. This is a hands-on, growth-focused role with opportunities to train others and contribute to process improvements across the lab.
Compensation / Benefits- bonus eligibility
- equal opportunity employer
Responsibilities- Conduct routine lab studies to support validation/qualification of medical devices for reprocessing in ASP sterilization systems
- Draft and communicate technical documents (protocols, test reports) using templates and prior studies
- Design and execute experiments under supervision to assess new technologies and product development stages
- Follow approved protocols, ensure proper documentation and thorough summarization of results
- Support lab equipment validation, OOS, CAPA, and investigations; assist higher-level scientists as needed
- Provide training to laboratory personnel on testing procedures
- Communicate testing status and results to stakeholders; raise business-relevant issues to management
- Support cross-program testing, process improvements, and awareness of sterilization/biocompatibility advances
- Perform other duties as assigned to support team goals
Key requirements- Bachelor's Degree in a scientific discipline such as Microbiology or Biology
- 0-2 years in a laboratory or related environment
- Understanding of laboratory safety and compliance with regulatory requirements
- Knowledge of sterilization, disinfection, and cleaning technologies for medical devices
- Experience or familiarity with GxP, FDA, ISO guidelines preferred
- Strong problem-solving, critical thinking, and ability to work independently or in a team
- Good oral and written communication skills; cross-functional collaboration
- Experience with sterilants, disinfectants, or medical washers/disinfectors preferred
- strong problem-solving
- clear communication
- team collaboration
- sterilization and disinfection technologies
- validation/qualification of medical devices
- GxP compliance (FDA/QSR/ISO)
