Engineer I, Quality at ICU Medical, Inc. in Southington, Connecticut

Job Description:

Job Description



Position Summary


Engineer I, Quality will support the ICU Quality Operations Department and report to the Quality Operations Manager. They are responsible for sustaining manufacturing and validations through adherence to established design control processes, good quality and documentation practices. The key responsibility of this position is to exercise judgement and act while adhering to defined quality procedures during project support & improvement. Engineer I, Quality 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


Immediate Responsibilities

• Support initiatives for continuous quality improvements.
• Under the guidance of the Quality leadership, work to improve performance of manufacturing systems, e.g. yield, cycle-time, quality requirements, maintenance needs.
• Support project timelines and milestones and bring them to completion on time and within budget.
• Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
• Quality technical expert for a manufacturing production line
• Create and edit documents to support Quality.
• Reference 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.

• Initiate and manage projects with adherence to program-management guidelines.
• Participate in vendor assessment and review of materials/machine technical information.
• Build productive relationships internally and externally.
• Work with Product, Manufacturing, and Molding Engineers on qualification activities for new or modified processes and equipment.
• 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 of the Medical Device Industry and familiarity with FDA QSR Regulations
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
• Technical writing competency
• Has engineering foundation.
• Expected to spend majority of time learning and best practices.
• Has a basic understanding of 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.

• Bachelor's degree from an accredited college or university in Engineering or STEM
• 0-2 years' experience (Medical Device or Engineering)
• Must be 18 years of age

• This is largely a sedentary role.
• Typically requires travel less than 5% of the time.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Must be able to occasionally move and lift objects of up to 25 pounds.