Quality Engineer Reprocessing Development

Primary Function of Position:
Intuitive designs and manufactures highly complex systems for use in robotic-assisted surgery
and minimally invasive lung biopsy. These systems employ a combination of reusable and
single-use devices for each procedure. The primary function of the Quality Engineer is to act
as a central company resource for cleaning disinfection and sterilization testing and validation
of reusable devices. This person will work with cross-functional teams to provide design inputs
that enable effective cleaning disinfection and sterilization of new reusable medical devices.
The Quality Engineer will conduct cleaning disinfection and sterilization validation testing
on-site or in cooperation with external laboratories to support domestic and international
regulatory submissions. This person must have a good working knowledge of domestic and
international standards related to reprocessing. This role may include interaction with final users
to understand central reprocessing procedures help streamline workflows and improve
instructions for use.
The successful candidate must excel in a high-energy high capacity and fast-paced
environment working with multidisciplinary teams to drive solutions from early design
requirements to product launch and support. Essential to this role is a high commitment to
product quality and the ability to learn rapidly and create innovative solutions. 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 and Responsibilities
Lead multiple validation and verification studies including cleaning disinfection and
sterilization involving rigorous data analysis with focus on the safety and efficacy of new
robotic medical devices.
Maintain reprocessing instructions for use (IFU) requirements including design control
activities harmonization of content across platforms and continuous improvement.

Concurrently oversee multiple projects requiring frequent communication and
collaboration between internal departments and outside services (vendors and
laboratories).
Define reprocessing test approach and test plans to ensure safety and efficacy for new
instrument and accessory products across the companys product platforms. Provide
subject matter expert input for design materials and product requirements for optimized
reprocessing output.
Collaborate with Regulatory Affairs to support domestic and international regulatory
submissions and approvals
Collaborate with Product Management to integrate user needs into reprocessing
instructions.
Develop and maintain procedures and best practices to ensure compliance with
applicable domestic and international cleaning disinfection and sterilization standards.
Optimize cleaning disinfection and sterilization control processes systems and
procedures.
Support development of harmonized reprocessing manuals for end users minimizing
reprocessing complexity and ensuring compliance with AAMI and ISO standards for
medical devices.
Good working knowledge of medical device industry standards and guidance for medical
device reprocessing.
Support field teams and other global teams across the organization on technical
inquiries related to reprocessing
Support field visits to central reprocessing customer sites and make recommendations
for improvements to streamline reprocessing workflows
Participate in AAMI working groups in the development of new standards in this field
Other duties as assigned

Qualifications :

Skill/Job Requirements
Competency is based on: education training skills and experience. To adequately
perform the responsibilities of this position the individual must have:

BS in Engineering Life Science Microbiology or technical equivalent; Masters is
preferred
Minimum of 5 years of experience in the medical device field
Familiarity with US and international medical device cleaning disinfection and
sterilization standards such as AAMI TIR 12 AAMI ST98 AAMI ST91 ISO 15883 ISO
17665 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 and manage 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 including statistical analysis tools.
Ability to travel to customer or laboratory sites (10%) including international travel.
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.

Additional Information :

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 Opportunity 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.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

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 compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time