Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201063
Primary Function of Position:
Intuitive Surgical designs and manufactures highly complex systems for use in surgery. These systems employ a combination of reusable and single use surgical instruments and accessories for each surgical procedure. The primary function of the Senior Validation Engineer - Sterility Assurance is to define sterilization studies, manage and complete sterilization validation, and maintain sterilization processes of existing single-use products. This person will act as the primary interface between internal project teams (e.g. Research and Development, Manufacturing Engineering, Supplier Engineering, Quality Engineering, etc.) and external laboratories and sterilizers.
The successful candidate must excel in a high-energy, high transaction, small and focused team environment, be able to drive to solutions from rough requirements, and have a commitment to high product quality and compliance. The ability to understand project goals and communicate test plans required to achieve those goals is 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 will be a technical and management team that knows and cares about what you are doing, and wants you to succeed.
Roles and Responsibilities:
- Manage routine Ethylene Oxide (EO) and radiation sterilization requalifications, coordinate with cross-functional teams, sterilizers, and laboratories and drive projects to completion.
- Investigate and provide technical justifications for excursions that may occur during routine EO sterilization of single-use medical devices.
- Provide technical expertise to the Quality Engineering team to assist with routine release of single-use devices and the bioburden program (e.g. interpretation of results, investigation of excursions, etc.).
- Lead sterilization validations, involving rigorous data analysis with focus on the safety and efficacy of single-use daVinci® surgical instruments and accessories for new products and sustaining projects (e.g. cost reduction, process improvements, etc.).
- Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (sterilizers, suppliers, and laboratories).
- Develop and validate sterilization processes in accordance with international standards (e.g. BS EN ISO 11135, BS EN ISO 11137) and maintain Intuitive Surgical procedures based on those standards.
- Implement projects per approved budget and schedule.
- With support from the sterilization team, conduct, review and approve incident investigations. Review corrective actions and develop reliable preventative actions related to sterilization as a result of any nonconformity.
- Assist with compliance audits for external facilities as required to support quality management system.
Competency is based on: education, training, skills and experience. In order to adequately perform the responsibilities of this position the individual must have:
- Bachelors of Science in Engineering, Life Science, Chemistry or technical equivalent; Masters is preferred
- Minimum 8 years of professional experience with Ethylene oxide; radiation sterilization experience is also desired.
- Expertise and working knowledge of international medical device sterilization standards, such as ISO 11135 and ISO 11137.
- Excellent verbal and written communication, teamwork, and interpersonal skills to work across multiple constituents.
- Self-starter with ability to take leadership in a fast-paced environment.
- Able to prioritize and smoothly manage multiple tasks.
- Able to manage project risk and timely escalate issues to senior management and team.
- Hands-on engineering skills with the proven ability to work well in a team environment and drive individual projects.
- Ability to focus, and attention to detail along with a strong track record of continuous improvement initiatives.
- Well versed in MS Office Suite.
- Ability to travel to supplier, sterilizer, or laboratory sites, including international travel.