Manager, Equipment Maintenance

General Summary

Under 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 Qualifications

Minimum 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 and FDA QSR

•Ability to effectively interface with maintenance supervisors and technicians from a wide variety of disciplines, cultures, and backgrounds

•High degree of accuracy and attention to detail

•Able to work independently, while effectively organizing and prioritizing their work, as well as coordinating the work of others, as needed

•Proficiency with Microsoft Office tools, including Word, Excel, and Outlook

•Demonstrated ability to identify and remediate equipment and personnel issues

Working Conditions

•General office, laboratory, and cleanroom environments

•Willingness and ability to work on site

•Potential exposure to blood-borne pathogens

•Requires some lifting and moving of up to 50 pounds, and occasionally up to 100 pounds with assistance. Requires occasional climbing on ladders up to 12 feet

•Must be able to move between buildings and floors

•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period each day

•Must be able to read, prepare emails, and produce documents and spreadsheets

•Must be able to move within the office and access file cabinets or supplies, as needed

•Must be able to communicate and exchange accurate information with employees at all levels daily

Annual Base Salary Range:  $129,000 - $179,000

This is the pay range for a high-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

What We Offer

•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.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.