Sustaining Engineer II

Description

Position Summary

Responsible for leading projects to include cross-functional team members to clear actions, milestones, and resolutions for on market product design related changes that impact supply to both the Southington and Keene production facilities. Work cross-functionally with R&D, Quality and or Design Assessors to resolve technical issues, including developing and driving working solutions and comprehensive mitigation plans.

Essential Duties & Responsibilities

• Resolve product and component needs and issues to ensure continuity of supply for all on Market Product for the Southington and Keene sites.

• Work with the Supplier Change Notification process and Supplier Quality regarding any issues, changes, or updates to supplied resins, components and materials used for production in the Southington and Keene sites.

• Work with R&D, Quality, Regulatory, Design Assessors and Plant Engineering to test components and or product to document and make changes or updates to ICU product documentation.

• Prepare and execute Change Management documentation to include Commodity Specs, Drawings, Change Management Control plans and Design and Development Plans as needed to ensure continuity of components, materials, and packaging materials.

• Communicate with management to provide updates on project status and or contingency plans to ensure continuity of supply of components and materials used for on-market product.

• Coordinate with ICU groups to prepare and execute Validations for Medical Packaging and Accelerated Aging Studies.

• Prepare presentations, graphs, plans, forms, reports, etc. or any other documents required, according to the nature of activities.

• Follow the standard operating procedures, rules and regulations established by entities related to the manufacture of medical products.

• Work on special projects as they arise or other responsibilities typical of a Sustaining Engineering Position to support on market product.

Knowledge & Skills

• Working knowledge of products manufactured in Southington and Keene plants.

• Minitab use for Statistics and Data Analysis.

• Microsoft Project.

• Ability to read technical specifications, drawings, and understand testing standards.

• Knowledge of plant quality requirements as to on market product.

• Strong communication skills for use in interfacing with internal and external suppliers and ICU management.

Minimum Qualifications, Education & Experience

• Bachelor's degree in Engineering from an accredited college or university is required.

• Minimum of 3 years in the medical device industry or a combination of medical device and pharmaceutical industry experience.

• Must be at least 18 years of age

Work Environment

• This job operates in a professional office environment and routinely uses standard office equipment.

• At times this job requires manufacturing site and supplier visits where good customer interface skills are required.

• Typically requires travel less than 10% of the time

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.