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Position Summary The Principal Manufacturing Engineer will represent the ICU Manufacturing Engineering Department and report to the Manufacturing or Product Engineering Manager. The Principal Manufacturing Engineer is responsible for identifying, owning and driving process improvements through adherence to established design control processes, good engineering and documentation practices. The key responsibility of this position is to be proactive, identify and execute actions to prevent future complaints & manufacturing challenges. This position is 100% onsite at our Southington, CT manufacturing plant. Essential Duties & Responsibilities · Functional area tasks and responsibilities o Day to day § Initiate and manage projects with adherence to program-management guidelines § Own and manage CAPA tasks and deliverables (Corrective and Preventive) § Lead vendor assessment and review of materials/machine technical information § Consult with Product and Molding Engineers on in-process non-conformances § Spearhead initiatives for continuous process improvements § Network with senior personnel to build successful relationships internal and external to the company § Area- or plant-wide process technical expert § Create and edit documents to support Production § Work with Quality Engineers on qualification activities for new or modified processes and equipment o Long term expectations § Use broad understanding from start to end of the product manufacturing process in the company to drive win-win solutions for both product quality and manufacturing § Bring clarity of thought, effectively challenge assumptions in a group setting. § Mentor entry level engineers § Be able to independently lead a team navigating through hurdles, achieve performance, consider input from multiple functional areas & address the problem through a holistic method Knowledge, Skills & Qualifications · Mastery in one or more key process areas: automation, medical-device assembly, controls, etc · Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques · Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) · Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations · Project management experience preferred · Solid works to interpret part dimensions, sectional views, conduct mates and build assemblies · Technical writing competency Education and Experience · Must be 18 years of age · Bachelor’s degree in Engineering or Technology · Medical Device Experience is a must · 10 years’ experience in the Medical Device or Engineering Industry Advanced Degree may substitute for experience 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. Title: Principal Engineer, Manufacturing Location: CT-Southington Requisition ID: 24300175