Engineer II, Manufacturing bei US Operating Unit

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 manufacturing site. Works with Supplier Changes and Supplier Change Notices in resolving issues, or updates to supplied resins, components and materials used for production. 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

• Resolving product and component needs and issues to ensure continuity of supply for all on Market Product for the Southington site. 
• Working with the Supplier Change Notification process and Supplier Quality in any issues, changes, or updates to supplied resins, components and materials used for production in the Southington site.
• Working with R&D, Quality, Regulatory, Design Assessors and Plant Engineering to test components and our product to document and make changes or updates to ICU product documentation.
• Preparing and executing 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.
• Communication with management to provide updates on project status and our contingency plans to ensure continuity of supply of components and materials used for on-market products. 
• Coordinate with ICU groups to prepare and execute Validations for Medical Packaging and Accelerated Aging Studies.
• Prepares presentations, graphs, plans, forms, reports, etc. or any other document that is required according to the nature of its activities.
• Follows 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. 
• Support initiatives for continuous process and product improvements
• 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)
• Work on special projects as they arise

Knowledge & Skills

• Bachelor’s degree in engineering from an accredited college or university is required.
• Minimum of 3 years in the manufacturing of medical devices industry or combination of medical device or pharmaceutical industry. 
• Ability to read technical specifications, drawings, and understand testing standards.
• Knowledge of plant quality requirements as to on market product.
• Communication skills with internal and external suppliers and ICU management.
• Ease of interpersonal relationships, communication skills and methodical problem solving.

Minimum Qualifications

• Must be at least 18 years of age
• Bachelor’s degree in engineering from an accredited college or university is required.
• Minimum of 3 years in the manufacturing of medical devices industry or combination of medical device or pharmaceutical industry. 

Travel Requirements 

• Typically requires travel less than 10% of the time

Physical Requirements and Work Environment 

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.

Physical Requirements and Work Environment

• Work is performed in a clean room environment and office 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
• At times this job requires manufacturing sites, and supplier visits where good customer interface skills are required.