Engineering Technician III, R&D at ICU Medical Inc

Southington, Connecticut, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jul, 26

Salary

0.0

Posted On

06 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical engineering, Prototyping, Test method validation, Troubleshooting, Solidworks, Technical drawing, Fixture design, Minitab, Data analysis, SOP development, Lean manufacturing, Six Sigma, GMP, FDA regulations, ISO 9001, Mentoring

Industry

Medical Equipment Manufacturing

Description

Position Summary Our engineering technicians’ team is an integral part of our R&D organization supporting new product development and post-launch product evolution. Responsibilities include performing research, building prototypes, validating test methods, inspecting products, support building test fixtures, conducting tests, analyzing, reporting, and presenting on data, ensuring sites are safe and clean, and reporting to the Lab supervisor/Manager. Serves as a mentor/trainer for others in the lab and helps define and lead continuous improvement activities. Key skills include an ability to troubleshoot equipment/testing, communicate effectively, and provide effective suggestions for improvement as well as demonstrating a sound understanding of engineering terminology and being able to work well in a team. Essential Duties & Responsibilities * Lab, inventory, and equipment maintenance * Performs technical work requiring competency in all conventional aspects of the Mechanical engineering department. * Participates in 6S and lean initiatives in the laboratories * Conducts work requiring judgment in the evaluations, selection and the adaptation of standard techniques, procedures, and criteria; devises new approaches to problems as encountered * Performs technical work requiring some independent evaluation, selection and application of standard techniques, procedures, and criteria within mechanical engineering * Devise new approaches to problems as encountered including proposed fixture design/features and solutions Develops tests and/or validates development tools of moderate or significant complexity. Compiles metrics and engineering data including validation testing output, etc * Complies records a data associated with mechanical engineering to include drawings/schematics, validation/capability testing etc * Collects troubleshooting data and supports analysis; prepares reports on findings and recommendations. Develops writes and maintains documents related to development SOP’s and procedures. Provides assistance to engineers with writing DVT’s engineering report, engineering investigations, WICO‘s and DR’s * Manages sample inventory from start to end of projects, real and accelerated aging, and general inventory * Analyzes data (including basic statistics) and reports/presents on timely basis * Routinely provides guidance and direction to other team members on project related activities * Participates in ICU Medical facilitated training and development programs designed to increase knowledge in issues related to medical device development, such as GMP, Quality Systems, etc., as well as their application at ICU Medical. Assists in Training laboratory technicians on the proper execution of test protocols and use of laboratory equipment. Trains laboratory technicians in the proper methods for documenting test data, including the use of laboratory notebooks * This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site) * Plans and conducts projects on a limited scope or portions of a larger projects. * Works with internal departments as well as vendors and equipment suppliers to resolve issues and coordinate work in support of ICU Medical objectives. * Engages others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement * Work on special projects as assigned by Lab Supervisor/Manager Knowledge & Skills * Knowledge of basic mechanical and related to medical devices and practice is required. * Basic Solidworks and technical drawing/drafting skill * Ability to design fixtures, testers, and assembly aids for production. * Basic knowledge of Minitab * Knowledge of validating methods * Knowledge and skill in engineering record keeping procedures and methods, with the ability to rapidly master ICU Medical internal procedures and methods. * Knowledge of QSSOPs, GMP/FDA/ISO 9001, etc., principles and ability to integrate into software engineering discipline * Basic knowledge of lean and Six Sigma Methods Minimum Qualifications, Education & Experience * Must be at least 18 years of age * High School Diploma required along with either 6 plus years’ work experience as an engineering technician in a related position within a manufacturing or testing organization, an associates degree in a related technical field with 4 plus years’ work experience, or a bachelor’s degree in a related technical field with 2 plus year’s work experience Work Environment * This is largely a sedentary role. * This job operates in a professional lab and office environment and routinely uses standard office equipment. * Work can be performed in a clean room environment * While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating * Operator is required to use computer or touch screen to enter work order data * Must be able to occasionally move and lift objects of up to 25 pounds ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings. We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you: * Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. * The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. * IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. * Significant US IV solutions manufacturing and supply capabilities. ICU Medical EEO Statement: ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates. ICU Medical EEO Policy Statement [https://www.icumed.com/media/lwkcbbam/icu-medical-eeo-policy-statement-2025.pdf] Know Your Rights: Workplace Discrimination is Illegal Poster [https://www.icumed.com/media/0mrnh211/know_your_right_2023-2.pdf] ICU Medical CCPA Notice to Job Applicants [https://www.icumed.com/media/1qwexl5a/icu-medical-job-applicant-privacy-notice-october-2024.pdf]

Responsibilities

The engineering technician will support R&D by building prototypes, conducting validation tests, and maintaining laboratory equipment. They are also responsible for analyzing data, writing technical reports, and mentoring other lab staff on procedures and compliance.