Clinical / Regulatory
United States-California-Santa Clara County-Sunnyvale
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position
The primary function of the Validation Engineer is to act as a company expert for sterilization validations of single use products. The person will be responsible for conducting validations using sterilization methods such as Ethylene oxide and Radiation. Thus he/she must have knowledge of requirements put forth by appropriate domestic and international standards. This person will act as the primary interface between internal accessory projects and external sterilizers and laboratories.
Roles and Responsibilities
- Act as team member on new accessory projects across the company to review design input, design output, and create verification and validation test strategies for overall suitability with respect to sterilization. This responsibility also includes giving the design team guidance on how to design for sterilization.
- Manage sterilization validation activities with external organizations and laboratories, coordinating interactions between the various product teams and the external labs, and work with internal regulatory personnel to communicate with regulatory bodies.
- Develop and maintain company-wide test programs and best practices to ensure compliance with domestic and international standards for cleanrooms and sterilization methods.
- Serve as a company expert on public information relating to sterilization of Intuitive Surgical products
- Understanding and communicating requirements from domestic and international standards on sterilization
- FDA guidance’s, white papers or other articles published on medical device sterilization and cleanrooms.
- Provide input and recommendations for other sterilization issues. For example: design and testing of sterilization trays, or evaluation of processes or technologies to clean ISI instruments and accessories.
- Manage work instructions in accordance to standards for sterilization of disposables.
- Provide guidance to Operations on impact on sterilization for certain design or packaging changes.
- Audit sterilizers to ensure compliance to appropriate standards.
- Create and communicate sterilization strategy for disposable products. For example: manage bioburden monitoring, cleanroom monitoring, cleanroom expansion studies, create product families.
- Perform other duties as assigned.
Core Competencies, Skills and Experience Requirements
Education and Training Requirements
- Medical device sterilization validation experience (an absolute must for this position) with knowledge of sterilization methods and experience with sterilization validations for single-use disposable products
- Experience working with external laboratories on sterilization validations for medical devices
- Familiarity with domestic and international medical device sterilization standards
- Prefer experience in these additional areas:
- Developing reprocessing procedures for complex medical devices
- Ability to travel to sterilizer or laboratory sites (10% to 15%), including international travel
- Cross-functional communication and teamwork skills
- Written and verbal communication skills
- Proficiency with customary business computer skills (such as word processing, spreadsheets)
- Demonstrated ability to work independently as well as in a team
- Ability to focus, and attention to detail along with a strong track record of continuous improvement initiative
- Experience with PDM tools such as Agile is preferred but not required
- BS in Engineering, Life Science, or technical equivalent; Masters preferred
- Prefer strong background in microbiology.
- 2 + years of experience in the medical device field (10 years preferred).
Intuitive Surgical - 19 months ago
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