Best Practices, Communication Skills, Critical Care, Cross-Functional, Customer Satisfaction, Customer/Client Research, Documentation, Drug Manufacturing, Functional Testing, Healthcare, Home Care, Hospital, Intensive Care, International News, Interoperability, Intravenous Therapies, Laboratory Equipment, Laboratory Management, Laboratory Techniques, Manufacturing, Medical Equipment, Medical Record System, Medications, Microsoft Excel, Microsoft Outlook, Microsoft Word, Office Equipment, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Receivers, Regulations, Regulatory Reports, Reporting Skills, Staff Training, Team Player, Time Management
Position Summary
The Engineer I, Quality - Complaints will methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner. The Engineer I will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed.
Essential Duties & Responsibilities
- Methodically process, and investigate, Medical Device customer feedback (complaints) in a high paced, efficient and accurate manner
- Identify critical dimensions on component drawings and submit dimensional inspection requests
- Carry out basic standardized test methods and/or submit functional testing requests
- Establish and maintain communication both internal and external (with the customers and regulatory personnel as needed)
- Domestic and International Regulatory vigilance reporting is essential
- Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
- References existing work to complete similar projects. Improves on previous work.
- Provides input to the product teams regarding the development of new designs, methods or processes.
- Works under supervision of more experienced engineers. Regular assignments are completed with minimum supervision.
- May assist in training new employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
- Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.
- Work on special projects as they arise
Knowledge & Skills
- A willingness and capability to work with used, and therefore contaminated Medical Devices in a controlled setting
- Take in and communicate information effectively
- Communicate externally as needed, and do so in a professional manner
- Knowledge of Microsoft Word, Excel, and Outlook
- Has engineering foundation.
- Expected to spend majority of time learning and best practices.
- Has a basic understanding engineering discipline.
- Willingness to learn/understand big picture.
- Ability to complete projects with minimum supervision.
- Requires the ability to provide input and recommendations that impact the completion of project goals.
Minimum Qualifications, Education & Experience
- Must be at least 18 years of age
- Bachelor's degree from an accredited college or university (Engineering, Technology, or STEM)
- 0-2 years experience
- Prior experience in quality assurance is preferred.
- Previous experience working in a regulated manufacturing or pharmaceutical/healthcare environment preferred but not required.
Work Environment
- This job operates in a professional office environment and routinely uses standard office equipment
- Work is performed in a safe environment.
- While performing the duties of this job, the employee is regularly required to work with contaminated Medical Devices in a controlled laboratory setting
- Must be able to occasionally move objects up to 15 lbs.
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
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