Senior Validation Engineer Sterility Assurance

medical device cleaning validation, medical device sterilization validation, environmental monitoring, microbiological testing, domestic and international medical device cleaning, AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28
Full Time
Depends on Experience
Work from home not available Travel required to 10%.

Job Description

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:

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 act as a central company resource for cleaning and sterilization validation of single use and reusable products, including knowledge of domestic and international standards and requirements. This person will act as the primary interface between internal instrument and accessory projects and external laboratories, and also work cross-functionally with a team to interface with customers regarding cleaning, disinfection, and sterilization issues for ISI instruments and accessories.

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. The ability to learn rapidly and a desire to understand requirements and create solutions 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 will be a technical and management team that knows and cares about what you are doing, and wants you to succeed.

Roles and Responsibilities:

  • Concurrently oversee multiple projects requiring frequent communication and collaboration between internal departments and outside services (vendors and laboratories)
  • Spearhead multiple cleaning, disinfection and sterilization validations, involving rigorous data analysis with focus on the safety and efficacy of new da Vinci surgical instruments and accessories
  • Develop reprocessing strategies to mitigate safety and efficacy risks for new instrument and accessory projects 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 streamline regulatory submission, approvals, and strategies.
    Develop and maintain procedures and best practices to ensure compliance with US and international standards
  • Optimize cleaning and sterilization control processes, systems, and procedures to support growth in production volumes, addition of manufacturing sites, and the addition of sterilization locations
  • Develop requirements and workflow for information technology tools and business systems for managing sterilization control
  • Support development of reprocessing manuals for da Vinci product families, minimizing reprocessing complexity and ensuring compliance with AAMI and ISO standards for medical devices
  • Working knowledge of industry regulations, standards, and guidance for medical device reprocessing
  • Support reviews of reprocessing practices at customer sites and make recommendations for improvements in reprocessing procedures
  • Perform compliance audits for external facilities as required to support quality management system
  • Other duties as assigned


Skill/Job Requirements:

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, Chemistry or technical equivalent; Masters is preferred
  • Minimum 8 years of professional experience in the medical device field, with at least 3 years of experience in:
  • Medical device cleaning validation experience
  • Medical device sterilization validation experience (steam, EO, radiation, and low- temperature processes)
  • Environmental monitoring, microbiological testing, and sterilization processes for single-use products
  • Developing reprocessing procedures/manuals and designing complex medical devices for reprocessing
  • Familiarity with domestic and international 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 take leadership in a fast-paced environment
  • Able to prioritize and smoothly manage multiple tasks
  • 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 initiative
  • Well versed in MS Office Suite
  • Ability to travel to customer or laboratory sites (10%), including international travel.

To apply:

All applications are accepted online through our career website. Please visit this link or click the apply now button below.

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Dice Id : RTL174963
Position Id : 191402_Shirala
Originally Posted : 4 months ago
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