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Senior Validation Engineer for Medical Devices
2 months ago
At Intuitive Surgical, we are seeking a highly skilled Senior Validation Engineer to join our team. As a pioneer in robotic-assisted surgery, we are committed to advancing the world of minimally invasive care.
Primary Function of PositionThe Senior Validation Engineer will 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.
Responsibilities- Drive multiple validation and verification studies, including cleaning, disinfection, and sterilization, with a focus on the safety and efficacy of new robotic medical devices.
- Oversee 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.
- Collaborate with Regulatory Affairs to support domestic and international regulatory submissions and approvals.
- Develop and maintain procedures and best practices to ensure compliance with applicable domestic and international cleaning, disinfection, and sterilization standards.
- Optimize cleaning, disinfection, and sterilization control processes, systems, and procedures.
- Support development of harmonized reprocessing manuals for end users, minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices.
To be successful in this role, you will need:
- BS in Engineering, Life Science, Microbiology, or technical equivalent; Masters is preferred.
- Minimum 8 years of professional experience in the medical device field, with at least 3 years in medical device cleaning validation, medical device sterilization validation, and flexible endoscope cleaning, disinfection, and sterilization validation.
- Familiarity with US and international medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, AAMI ST98, AAMI ST91, ISO 15883, ISO 11135, ISO 11137, AAMI TIR 28.
- Excellent verbal and written communication, teamwork, and interpersonal skills to work across multiple constituents.
- Self-starter with ability to steer 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 examination tools.
- Ability to travel to customer or laboratory sites (10%), including international travel.
