Sr Engineering Change Control Analyst

About This Role

The Sr Engineering Change Control Analyst will support medical device design, manufacturing, and quality assurance processes. This role involves analyzing change complexity, resolving issues with cross-functional departments, and ensuring compliance with governing procedures.

Responsibilities

• Analyze the varying complexity of changes and resolve issues with collaboration from cross-functional departments
• Understand Product Lifecycle Management, ERP, and other Change Control processes and relationships
• Multitask and handle variable loads independently within multiple systems (Windchill PLM, JDE)
• Support and process change packages against governing procedures, interact with departments to complete, and release the final change package
• Perform the incorporation of approved changes to documentation (e.g, JDE data entry and verify correct implementation)
• Participate in special projects, complete assigned tasks, and deliverables
• Evaluate changes proposed by initiators and provide feedback
• Lead small-scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives
• Drive to resolve issues completely and with speed by leveraging your network of key contacts outside your own area of expertise
• Drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation

Requirements

• 5-7 years of experience in engineering change control processes and documentation
• Experience working with engineering/manufacturing information (BOMs, Drawings, manufacturing processes)
• Experience with a PLM system
• Experience in a quality and/or manufacturing environment in the medical device or pharma industry

Qualifications

• Bachelor's Degree or equivalent in a related field of study
• 5-7 years of experience in engineering change control processes and documentation, with experience in a quality and/or manufacturing environment in the medical device or pharma industry.

Nice to Have

• Windchill PLM experience
• Proven expertise in MS Office Suite
• Excellent written and verbal communication, negotiation, and relationship management skills
• Strong problem-solving and critical thinking skills
• Good understanding of medical device documentation development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Adherence to compliance with internal procedures

Skills

* Required skills