Create comprehensive documentation for equipment used by R&D teams, including user manuals, technical specifications, and safety guidelines
Serve as the go-to resource for engineering staff, providing guidance on tool management processes, documentation, and equipment procurement
Organize and maintain equipment files within the PLM system for existing equipment
Ensure accuracy and completeness by revising existing equipment files, including TCO and maintenance records
Collaborate with QA and Design Control to ensure equipment compliance with regulatory and quality standards assisting with equipment requirements and validation assessments
Maintain an accurate inventory of tools and equipment, tracking their availability, location, and condition
Oversee the equipment tracking system, ensuring timely updates and data integrity
Monitor equipment utilization and identify opportunities for optimization or replacement
Coordinate equipment training sessions for users, ensuring proper usage and safety protocols
Performs or supports execution of small repairs as directed
Performs other duties as necessary
Requirements
High School Diploma / GED and 6+ years working in a laboratory environment, or Associates and 4+ years
Self-starter, detail-oriented, and effective verbal/written communicator
Ethical, responsible, and data-driven decision-making methodology
Ability to organize work and judge priorities with guidance
Experience creating technical documentation for complex equipment
Familiarity with PLM systems (ex. Arena) and document management
Knowledge of validation processes and regulatory requirements
Experienced with building relationships with engineering staff and vendors
Working knowledge of Enterprise Asset Management software (ex. SAP)
Experienced with GDP (accurate recordkeeping)
Understanding of procurement and inventory control
Office software proficiency (Word, Excel) and technical writing capabilities
Experience in a medical device regulated environment