Jobs and Careers
PE
Manager, Equipment Maintenance, Alameda
PenumbraUnited Statesfull_timeVerifiedPosted 21 Apr 2025
💰 $179,000/yr($129,000/yr – $179,000/yr)
About the role
General SummaryUnder the general direction of upper management, the Equipment Maintenance Manager position is responsible for administering the Equipment Team’s day-to-day staffing, materials, equipment, and necessary resources, including vendors required to maintain the equipment in the CERs, and provide support to Production. Further, the Equipment Maintenance Manager oversees equipment maintenance and calibration activities, and ensures that equipment maintenance, calibration, and qualification activities are performed in accordance with Quality system requirements documented in SOP’s and WI’s. This position may be responsible for administrative tasks for the company’s equipment technicians, planner/schedulers, and equipment engineering specialists, including timecard and leave approvals.
Specific Duties and Responsibilities•Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans, this includes holding leaders responsible for ensuring performance reviews are done appropriately and “on-time.” *•Oversee the development of equipment maintenance supervisors, planner/schedulers, and/or equipment engineering specialists. Establish objectives, assign responsibilities, and provide ongoing performance feedback, including evaluations, development plans, and corrective actions when necessary. **•Work with supervisors, equipment engineering specialist, and planner/schedulers to prioritize PM’s, Calibrations, scheduled and unscheduled repairs and equipment related issues, coordinating with Production, Quality Control, and Engineering departments, as well as technician schedules. *•Ensure that staff are trained and following maintenance procedures in compliance with EB instructions. *•Ensure Audit readiness by validating equipment files, equipment labeling, and housekeeping to ensure that the equipment and/or calibration department is audit ready at all times (ISO, FDA, and internal audits). *•Work with Supervisors and Planner/Schedulers to ensure that spare parts needed for equipment maintenance activities are available, by managing the process of purchasing and inventorying activities. *•Work with Equipment Engineering Specialists to ensure that measurement equipment needed for equipment maintenance activities is available, by ensuring that purchasing and calibration activities are being facilitated. *•Allocate resources to ensure that daily workload is efficiently completed. *•Review and approve purchase requisitions for the procurement of spare parts, fixtures, and manufacturing equipment. *•As needed, create, or modify procedures to help the department run more efficiently.•As needed, suggest changes, and/or modify the overall structure of the department to better support employees and management.•Partners with stakeholders in cross functional departments such as Production, Engineering and Site Services (including Facilities, Security, EH&S, etc.).•Effectively communicates with customers who use the equipment, as well as vendors•Provide feedback in the development of prototypes and fixtures.•Justify and execute capital projects as needed to increase the capacity and efficiency of the department and company.•Provide input for improvement of Equipment Binders (EB), Work Instructions (WI), Standard Operating Procedures (SOP).•Manage NCR’s and CAPA’s for systematic improvements within the Equipment Maintenance department.•Responsible for management and progression of special projects.•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 QualificationsMinimum education and experience:•Bachelor’s degree with 8+ years of direct equipment maintenance experience, preferably in a cleanroom environment, and 5+ years of managerial experience, or an equivalent combination of education and experience
Additional qualifications:•Demonstrated leadership qualities preferred•Strong and effective oral, written, and interpersonal communication skills•Familiarity with regulatory requirements and standards, such as ISO 13485 an
Specific Duties and Responsibilities•Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans, this includes holding leaders responsible for ensuring performance reviews are done appropriately and “on-time.” *•Oversee the development of equipment maintenance supervisors, planner/schedulers, and/or equipment engineering specialists. Establish objectives, assign responsibilities, and provide ongoing performance feedback, including evaluations, development plans, and corrective actions when necessary. **•Work with supervisors, equipment engineering specialist, and planner/schedulers to prioritize PM’s, Calibrations, scheduled and unscheduled repairs and equipment related issues, coordinating with Production, Quality Control, and Engineering departments, as well as technician schedules. *•Ensure that staff are trained and following maintenance procedures in compliance with EB instructions. *•Ensure Audit readiness by validating equipment files, equipment labeling, and housekeeping to ensure that the equipment and/or calibration department is audit ready at all times (ISO, FDA, and internal audits). *•Work with Supervisors and Planner/Schedulers to ensure that spare parts needed for equipment maintenance activities are available, by managing the process of purchasing and inventorying activities. *•Work with Equipment Engineering Specialists to ensure that measurement equipment needed for equipment maintenance activities is available, by ensuring that purchasing and calibration activities are being facilitated. *•Allocate resources to ensure that daily workload is efficiently completed. *•Review and approve purchase requisitions for the procurement of spare parts, fixtures, and manufacturing equipment. *•As needed, create, or modify procedures to help the department run more efficiently.•As needed, suggest changes, and/or modify the overall structure of the department to better support employees and management.•Partners with stakeholders in cross functional departments such as Production, Engineering and Site Services (including Facilities, Security, EH&S, etc.).•Effectively communicates with customers who use the equipment, as well as vendors•Provide feedback in the development of prototypes and fixtures.•Justify and execute capital projects as needed to increase the capacity and efficiency of the department and company.•Provide input for improvement of Equipment Binders (EB), Work Instructions (WI), Standard Operating Procedures (SOP).•Manage NCR’s and CAPA’s for systematic improvements within the Equipment Maintenance department.•Responsible for management and progression of special projects.•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 QualificationsMinimum education and experience:•Bachelor’s degree with 8+ years of direct equipment maintenance experience, preferably in a cleanroom environment, and 5+ years of managerial experience, or an equivalent combination of education and experience
Additional qualifications:•Demonstrated leadership qualities preferred•Strong and effective oral, written, and interpersonal communication skills•Familiarity with regulatory requirements and standards, such as ISO 13485 an
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