Reprocessing Content Engineer

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 Reprocessing Content Engineer 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

Skills, Experience, Education, & Training:

• Minimum 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 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 TIR12, AAMI ST98, and ISO 17664.
• 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, support 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
• Ability to travel to customer sites or conferences (10%), including international travel.  

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

EEO and AA Policy

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.