Calibration and Equipment Systems Engineer I

Penumbra; Alameda (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental

401(k) with employer match

Paid parental leave

Holidays and vacation

Job summary

Penumbra, Inc. in Alameda, California is seeking a Calibration and Equipment Systems Engineer I to be a SME in calibration and metrology within the Equipment Maintenance department.

You will lead OOT investigations, support equipment qualifications and change controls, and guide calibration staff while partnering with IT to ensure data integrity. You will help develop and maintain asset management tools and databases, align with QMS standards, and contribute to audit readiness and continuous

Qualifications

• Experience in a regulated industry (medical device/pharma/biotech) preferred.
• Strong technical and math skills with good written and verbal communication.
• Ability to interface with multiple disciplines and cultures.
• Familiarity with CMMS/asset management software and data tools.

Responsibilities

• Serve as SME on equipment calibration requirements, procedures and best practices.
• Lead out-of-tolerance investigations and document root cause analyses.
• Collaborate with maintenance, manufacturing and quality teams to improve calibration programs.
• Manage equipment setup, qualification, and changes; support audits and change controls.
• Develop and maintain equipment asset databases; work with IT to ensure data integrity.

Skills

Calibration SME

OOT investigations

QA/QMS awareness

Communication

Microsoft Office

Education

Bachelor's degree in engineering

Tools

Power BI

Tableau

SQL

ServiceNow

CMMS/Asset management

Excel

Job description

General Summary

The Calibration and Equipment Systems Engineer I serves as a subject matter expert (SME) in calibration and metrology within the Equipment Maintenance department. This position plays a critical role in maintaining the integrity of measurement systems used across Production, Quality, and R&D. The engineer leads out-of-tolerance (OOT) investigations, supports equipment qualifications and change controls, and provides technical guidance to calibration staff. In addition, supports the development and maintenance of equipment asset management software tools and databases, and interfaces with IT to ensure data integrity and system reliability. Ensures alignment with internal Quality Management System (QMS) procedures and applicable regulatory standards, contributing to audit readiness, continuous improvement, and equipment compliance across the organization.

Specific Duties and Responsibilities

• Serve as key point of contact for technical expertise on equipment calibration requirements, procedures, and best practices, including traceability, measurement uncertainty, and evaluation of calibration suppliers.
• Lead out-of-tolerance (OOT) investigations, including product impact assessments, root cause analysis, and QMS documentation.
• Collaborate cross-functionally with Equipment Maintenance, Manufacturing, and Quality teams to improve calibration programs and resolve equipment-related compliance issues.
• Manage equipment setup and qualification processes during the construction orreorganization of production lines.
• Collaborate with IT to support system integrations and troubleshoot database or software issues.
• Develop, maintain, and improve equipment asset database, ensuring data integrity, traceability, and system reliability.
• Crosstrain equipment engineering specialists and end users on the calibration review system and assist in resolving issues.
• Manage 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.
• Support internal and external audits, providing calibration and equipment maintenance documentation.
• Identify and implement improvements to calibration processes and equipment documentation by authoring engineering change orders (ECOs).
• Proactively purchase and calibrate measurement equipment needed for equipment maintenance and engineering activities, maintaining Kanban inventory for production use.
• 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 in mechanical, electrical, biomedical, or industrial engineering, or related field, with 2+ years of experience, or equivalent combination of education and experience

Additional qualifications:

• Experience in a regulated industry, medical device, pharmaceutical, or biotech 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
• Familiarity with CMMS/asset management software, experience with ServiceNow a plus
• Experience with database management, SQL, or custom tool development preferred
• Experience with data visualization or reporting tools (e.g., Power BI, Tableau) is a plus
• Experience working with external calibration vendors
• Proficiency working in a Microsoft Office environment
• High degree of accuracy and attention to detail
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

Working Conditions

• General office, laboratory, and cleanroom environments
• Willingness and ability to work on site. May have business travel from 0% - 10%
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• 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 of time 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 alllevels on a daily basis.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified

Annual Base Salary Range: $70,000 - $90,000

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.

$70,000 - $90,000 a year

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, 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.