Equipment Engineering Specialist II

General Summary Date Created:

The Equipment Engineering Specialist II supports the manufacturing engineering department at Penumbra by independently executing tasks within the various equipment systems used in support of Production, Quality Inspection, and R&D. These include the calibration system, equipment asset folders, the Equipment database, and other databases used by the department including spare parts inventory and fixtures database. The Specialist has responsibilities within the calibration system, including scheduling and reporting on assets due for calibration, interfacing with calibration suppliers and department coordinators, and reviewing and approving calibration records. The equipment database responsibilities include asset tracking, updating records in the asset folders and equipment database, and ensuring assigned tasks are completed on time. Spare parts inventory responsibilities include tracking spare parts quantities on hand and re-ordering spare parts as needed. Fixture database responsibilities include quoting, ordering, and managing the assembly and inspection of Production fixtures.

Specific Duties and Responsibilities

• Generate and maintain weekly reports of assets due for calibration*
• Coordinate with department coordinators to ensure that calibrations are performed ontime*
• Create shippers for calibration suppliers and ensure that equipment is dropped off at the pick-up location*
• Retrieve calibrated equipment and calibration certificates from the drop-off location
• Independently perform technical review of calibration certificates and stickers to ensure that calibrations performed meet requirements; Identify out of tolerance conditions on calibration certificates*
• Cross-Train equipment specialists and department coordinators on the calibration system responsibilities and assist them in resolving issues*
• Schedule on-site calibrations and work with technicians to ensure calibrations are performed appropriately*
• Coordinate Penumbra’s inventory of production, quality, and R&D equipment including tracking of equipment status and location changes, adding new assets to, and updating the equipment database*
• Working with Equipment Maintenance and Equipment Engineering Supervisors, proactively purchase and calibrate measurement equipment needed for equipment maintenance and engineering activities, as well as establishing and maintaining Production Kanban
• Track usage of equipment spare parts and perform physical inventory*
• Purchase and replace spare parts and keep spare parts inventory database up to date. Update Kanban minimum quantities as appropriate to support Equipment Maintenance group*
• Work with internal and external machine shops to quote and order fixtures for production
• Coordinate with maintenance technicians and IQC to assemble and inspect fixtures for production*
• Maintain equipment files, equipment labeling, and housekeeping to ensure that the equipment area is always audit ready (ISO, FDA, and internal audits) *
• Perform 5S optimization of equipment areas and create tool inventories
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
• Perform other work-related duties as assigned.

*Indicates an essential function of the role

Position Qualifications Minimum education and experience:

• High School diploma with 3+ years of experience using databases, working within a regulated environment and completing/reviewing quality records; or equivalent combination of education and experience Additional qualifications:
• Bachelor’s degree preferred
• Strong technical/math skills and strong oral/written communication skills
• Ability to effectively interface with employees from a wide variety of disciplines, cultures, and backgrounds
• Proficient in a Microsoft Office environment
• Proficient working with databases
• Medical device, pharmaceutical, biotech, or other regulated industry experience desired
• High degree of accuracy and attention to detail
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously