Quality Engineer -- Sterilization and Reprocessing

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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 Quality Engineer -- Reprocessing and Sterilization is to develop user documentation for reprocessing of Intuitive instruments, endoscopes, and accessories. This includes reprocessing instructions for use, wall charts, customer notifications, etc. for new products, product design enhancements, and field issues. The Reprocessing Content 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. This role will also include streamlining workflows and improving 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.

Roles & Responsibilities:

• Develop reprocessing content as part of customer facing documents for new and existing products including organization and improvements.
• Maintain reprocessing instructions for use (IFU) requirements including design control activities, harmonization of content across platforms, and continuous improvement.
• Work with a cross-functional team to standardize reprocessing content for US and international end users.
• Collaborate with product management to integrate user needs into reprocessing instructions.
• Execute reviews of reprocessing user documentation as part of departmental procedures.
• Ensure compliance of reprocessing instructions with AAMI and ISO standards for medical devices.
• Ensure reprocessing content is based on approved test plans to ensure safety and efficacy for new instrument and accessory products across the company’s product platforms.
• Provide support to field teams and global teams across the organization on inquiries related to customer facing reprocessing documents.
• Track, triage, and manage requests for updates to reprocessing content from multiple global sources.
• Solicit information from different global teams and/or support field visits to customer sites to improve and streamline reprocessing workflows.
• Collaborate with Regulatory Affairs to support regulatory submission and approvals.
• Good working knowledge of medical device industry, standards and guidance for medical device reprocessing.
• Other duties as assigned

Qualifications

Skills, Experience, Education, & Training:

• BS in Engineering, Life Science, Microbiology or technical equivalent
• Minimum 2 years of professional experience in the medical device field, with emphasis on:
  • Medical device cl