Calibration and Equipment Systems Engineer I

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 or reorganization 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.

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 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 all levels on a daily basis