Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 200840
Primary Function of Position:
Intuitive Surgical designs and manufactures highly complex systems for use in robotic surgery. These systems employ a combination of reusable surgical instruments and accessories for each surgical procedure. The primary function of the Senior Validation Engineer is to provide design input early in the development process for cleaning and sterilization approaches, validation of reusable products, instructions for use, as well as, to support ongoing product design enhancements and field issues. Senior Validation Engineer needs to have a good working knowledge of domestic and international standards related to reprocessing. This person will act as the primary interface for cross-functional teams supporting development of new instruments, accessories and endoscopes, as well as, external laboratories. The primary responsibility is to provide cross-functional teams with appropriate design inputs for cleaning, disinfection and sterilization for ISI reusable devices and conduct validations to support 510(k) submissions. This role may include interaction with final users to understand central reprocessing processes, help streamline workflows and improve instructions for use.
The successful candidate must excel in a high-energy, high capacity, working in a fast pace environment with multidisciplinary teams to drive to solutions from early design requirements to product launch and support. The ability to learn rapidly, create innovative solutions and high commitment to product quality are essential. 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.
- Lead multiple validation and verification studies including cleaning, disinfection and sterilization involving rigorous data analysis with focus on the safety and efficacy of new da Vinci surgical 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 regulatory submission (510(k)) and approvals
- Develop and maintain procedures and best practices to ensure compliance with applicable US and international cleaning and sterilization standards.
- Optimize cleaning 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 on AAMI working groups in the development of new standards in this field
- Other duties as assigned
Competency is based on: education, training, skills and experience. In order to adequately perform the responsibilities of this position the individual must have:
- 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 experience
- Medical device sterilization validation experience (including steam and low- temperature modalities)
- Developing reprocessing instructions/manuals for complex medical devices
- Familiarity with US and international (OUS) medical device cleaning, disinfection, and sterilization standards such as AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28.
- 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, 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.
- Ability to travel to customer or laboratory sites (10%), including international travel.