Equipment Engineering Specialist II

• 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.

• 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

• A collaborative teamwork environment where learning is constant, and performance is rewarded.

• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra