Engineer

• Oversee and facilitate Change Review Board meetings to ensure change requests are properly documented, reviewed, and approved/rejected.
• Oversee and facilitate Change Review Board meetings to ensure plans to implement approved and verified changes are complete, appropriate, and properly executed by the operations implementation team.
• Create appropriate tasks in the Product Lifecycle Management (PLM) system to execute approved design changes included the proper sequencing of implementation and maintenance of records documenting design changes.
• Support New Product Introduction teams in DHF and DMR releases. Of critical importance is to ensure adequate support prior to critical project gates and milestones.
• Perform periodic review and collaborates updates of C&CM procedures as peripheral tools, and performs test of PLM tool as needed.
• Support PLM software updates by participating in demonstrations, UATs, training sessions and updating procedures. Review implementation plans and/or updates to peripheral tools or processes that may affect the way of working with the PLM system. Work with PLM end users to provide guidance on best practices and ways of working.
• Creat CR,CN,ECT,MCT and approval followup.
• CR closer time tracking.

To succeed in this role, you should have the following skills and experience:

• Bachelor of Science degree in a Technical, Science, or Engineering discipline
• Must have working knowledge of 21 CFR 820, 21 CFR Part 11 and ISO 13485
• Experience with Windchill PLM strongly desired.
• Advanced Microsoft Office skills: Word: Forms, Mail Merge, Index and Tables Excel: Forms, Formulas, & Graphs
• Strong attention to detail.
• Strong organizational skills and ability to prioritize workflow to meet established timeframes
• Ability to coordinate the work of others, monitor work for accuracy and provide appropriate feedback as needed
• Strong interpersonal communication skills to drive timely and accurate results
• Proven experience working with product and process change implementation
• Ability to maintain updated knowledge of procedures, products, key employee contacts and activities of assigned area
• Ability to work with team across different time zones.
• Systematically analyzes problematic situations and develops solutions consistent with organization objectives and procedures
• Will be required to travel up to 10% of time to travel both domestically and internationally to IGT-Devices offices, depending on the needs of the company.