Intuitive
medical device
ReprocessingandSterilizationDevelopmentEngineer
Neural analysis suggests this role is
optimal for mid candidates.
“Reprocessing and Sterilization Development Engineer at Intuitive. Skills: cleaning, disinfection, and sterilization testing and validation of reusable devices, domestic and international standards related to reprocessing, validation and verification studies, reprocessing instructions for use (IFU) requirements, reprocessing test approach and test plans. act as a central company resource for cleaning, disinfection, and sterilization testing and validation of reusable devices. provide design input”
What You'll Achieve.
enable effective cleaning, disinfection, and sterilization of new reusable medical devices; support domestic and international regulatory submissions; ensure safety and efficacy for new instrument and accessory products; optimized reprocessing output; ensure compliance with applicable domestic and international cleaning, disinfection, and sterilization standards; minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices; improvements to streamline reprocessing workflows
Industry & Context.
drive solutions from early design requirements to product launch and support; problems we solve demand creativity, rigor, and collaboration
Ability to travel to customer or laboratory sites (10%), including international travel., may require that you show current proof of vaccination against certain diseases including COVID-19.
What They're Looking For.
Must Have
Minimum of 1 years of experience in the medical device field, Familiarity with US and international medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, AAMI ST98, AAMI ST91, ISO 15883, ISO 17665, and ISO 17664, Superior verbal/written communication, teamwork, and interpersonal skills to work across multiple constituents., Self-starter with ability to lead in a fast-paced environment., Able to prioritize and manage multiple projects and focus execution, Hands-on experience with proven ability to work well in cross-functional team environment and meet project goals, Attention to detail along with flexibility to support various projects, Well versed in MS Office Suite including statistical analysis tools.
Nice to Have
technical Masters is preferred
What You'll Do.
act as a central company resource for cleaning
and sterilization testing and validation of reusable devices
provide design inputs that enable effective cleaning
and sterilization of new reusable medical devices
and sterilization validation testing on-site or in cooperation with external laboratories to support domestic and international regulatory submissions
interact with final users to understand central reprocessing procedures
help streamline workflows
and improve instructions for use
Assist with validation and verification studies including cleaning
and sterilization involving rigorous data analysis with focus on the safety and efficacy of new robotic medical devices.
Maintain reprocessing instructions for use (IFU) requirements including design control activities
harmonization of content across platforms
and continuous improvement.
Concurrently assist with multiple projects requiring frequent communication and collaboration between internal departments and outside services (vendors and laboratories).
Define reprocessing test approach and test plans to ensure safety and efficacy for new instrument and accessory products across the company’s product platforms.
Provide subject matter expert input for design
and product requirements for optimized reprocessing output.
Collaborate with Product Management to integrate user needs into reprocessing instructions.
Develop and maintain procedures and best practices to ensure compliance with applicable domestic and international cleaning
and sterilization standards.
and sterilization control processes
Support development of harmonized reprocessing manuals for end users
minimizingreprocessing complexity and ensuring compliance with AAMI and ISO standards formedical devices.
Support field teams and other global teams across the organization on technical inquiries related to reprocessing
Support field visits to central reprocessing customer sites and make recommendations for improvements to streamline reprocessing workflows
Participate in AAMI working groups in the development of new standards in this field
Other duties as assigned
How You'll Work.
Team & Collaboration
work with cross-functional teams; work across multiple constituents; work well in cross-functional team environment; frequent communication and collaboration between internal departments and outside services (vendors and laboratories); Collaborate with Product Management; Support field teams and other global teams across the organization
Communication Scope
Superior verbal/written communication; frequent communication
Process & Methodology
manage multiple projects, focus execution, meet project goals
Full Job Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of Position: Intuitive designs and manufactures highly complex systems for use in robotic-assisted surgery and minimally invasive lung biopsy. These systems employ a combination of reusable and single-use devices for each procedure. The primary function of the Development Engineer is to act as a central company resource for cleaning, disinfection, and sterilization testing and validation of reusable devices. This person will work with cross-functional teams to provide design inputs that enable effective cleaning, disinfection, and sterilization of new reusable medical devices. The Development Engineer will conduct cleaning, disinfection, and sterilization validation testing on-site or in cooperation with external laboratories to support domestic and international regulatory submissions. This person must have a good working knowledge of domestic and international standards related to reprocessing. This role may include interaction with final users to understand central reprocessing procedures, he
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