Senior Quality Engineer, Sterilization and Reprocessing
4 weeks ago
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 Senior Validation 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 Senior Validation 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, help streamline workflows, and improve instructions for use.
The successful candidate must excel in a high-energy, high capacity, and fast-paced environment working with multidisciplinary teams to drive solutions from early design requirements to product launch and support. Essential to this role is a high commitment to product quality and the ability to learn rapidly and create innovative solutions. A strong sense of shared responsibility and shared reward is required, as is the ability to make work fun and interesting. Supporting this role is a management team that is invested in what you do and wants you to succeed.
Roles and Responsibilities
•Lead multiple validation and verification studies including cleaning, disinfection, and sterilization involving rigorous data analysis with focus on the safety and efficacy of new robotic medical devices.
•Concurrently 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. Provide subject matter expert input for design, materials, and product requirements for optimized reprocessing output.
•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.
•Good working knowledge of medical device industry standards and guidance for medical device 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
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