Calibration and Equipment Systems Engineer I

• 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. *Indicates an essential function of the role

• 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

• 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

• 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. •

• 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