Reprocessing and Sterilization Development Engineer

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 Development 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 Development 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 company’s 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

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.