Staff, Document Specialist & Business Systems Analyst - Engineering Group

Staff-level position leading documentation governance, engineering change management, and product lifecycle initiatives within the Engineering group. Combines document control expertise with business systems analysis to drive PLM 2.0 implementation and cross-functional process improvements in a highly regulated medical device environment.

Responsibilities

• Create, maintain, and release engineering documents, drawings, software artifacts, and BOMs using ALM, PDM, and PLM systems
• Lead PLM 2.0 evaluation, selection, implementation, and adoption including requirements management and deployment activities
• Establish governance for product data, master data, and cross-system traceability across PLM, ERP, MES, and QMS platforms
• Translate business needs into scalable processes, system requirements, and implementation roadmaps for efficiency and compliance improvements
• Mentor team members and users on document control, change management, PLM processes, and business systems best practices

Requirements

• Bachelor's degree in Engineering, Information Systems, Computer Science, or related technical discipline
• Minimum 15 years experience in engineering, manufacturing, business systems, or regulated product development
• Expert-level knowledge of engineering document control, change management, product data governance, and BOM management
• Hands-on experience with PLM platforms such as Oracle Agile, Windchill, Teamcenter, or Enovia
• Proven track record leading PLM implementations, migrations, or major system transformations
• Working knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, and quality system compliance
• Demonstrated ability to lead cross-functional initiatives and influence senior stakeholders independently