The Equipment Engineering Specialist I support the manufacturing engineering department at Penumbra by 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.

• Generate and maintain weekly reports of assets due for calibration*

• Coordinate with department coordinators to ensure that calibrations are performed on-time*

• 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

• With guidance from Supervisor or higher-level specialist, perform technical review of calibration certificates and stickers to ensure that calibrations performed meet requirements; Identify out of tolerance conditions on calibration certificates*

• Schedule on-site calibrations and work with technicians to ensure calibrations are performed appropriately*

• Keep up to date 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*

• Coordinate purchasing and calibration activities for measurement equipment needed for equipment maintenance and engineering activities

• Track usage of equipment spare parts and perform physical inventory*

• Purchase and replace spare parts and keep spare parts inventory database up to date*

• 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

• High School diploma with 2+ years of experience using databases, working within a regulated environment and completing/reviewing quality records; or equivalent combination of education and experience

• 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

• Production/Lab/Controlled Environment Room (CER)

• Business travel from 0% - 10%

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds

• The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception

•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, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.