Calibration and Equipment Systems Engineer I
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
About the opportunity
The Calibration and Equipment Systems Engineer I serves as a subject matter expert in calibration and metrology within the Equipment Maintenance department at Penumbra.
This position maintains the integrity of measurement systems used across Production, Quality, and R&D by leading out-of-tolerance investigations, supporting equipment qualifications, and providing technical guidance.
The role involves supporting equipment asset management software tools, collaborating with IT for data integrity, and ensuring strict alignment with internal Quality Management System procedures
and applicable regulatory standards to maintain audit readiness and compliance.
Key responsibilities
- Serve as key point of contact for technical expertise on equipment calibration requirements, procedures, and best practices, including traceability and measurement uncertainty.
- Lead out-of-tolerance (OOT) investigations, including product impact assessments, root cause analysis, and QMS documentation.
- Collaborate cross-functional with Equipment Maintenance, Manufacturing, and Quality teams to improve calibration programs and resolve compliance issues.
- Manage equipment setup and qualification processes during production line construction or reorganization.
- Develop, maintain, and improve the equipment asset database to ensure data integrity, traceability, and system reliability.
- Manage Penumbra inventory of production, quality, and R&D equipment, including status tracking and asset updates.
- Support internal and external audits by providing calibration and equipment maintenance documentation.
- Identify and implement improvements to calibration processes and equipment documentation by authoring engineering change orders (ECOs).
- Adhere to and ensure department compliance with the Company Quality Management System and relevant quality regulations.
Qualifications
- 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.
- Strong technical, mathematical, oral, and written communication skills.
- Ability to effectively interface with employees from a wide variety of disciplines, cultures, and backgrounds.
- Familiarity with CMMS/asset management software.
- Proficiency working in a Microsoft Office environment with a high degree of accuracy and attention to detail.
- Excellent organizational skills with the ability to prioritize assignments while handling multiple projects simultaneously.
Nice to have
- Experience in a regulated industry, medical device, pharmaceutical, or biotech.
- Experience with ServiceNow.
- Experience with database management, SQL, or custom tool development.
- Experience with data visualization or reporting tools such as Power BI or Tableau.
- Experience working with external calibration vendors.
Benefits
- Competitive annual base salary range of $70,000 to $90,000.
- Comprehensive compensation package including benefits and equity program where applicable.
Job details
- Location: On-site work required in general office, laboratory, and cleanroom environments.
- Business travel: 0% - 10%.
- Physical requirements include lifting and moving up to 25 pounds, moving between buildings and floors, and extended periods of computer use.
About the company
Penumbra is a global healthcare company focused on innovative therapies. The company designs, develops, and manufactures novel products with the goal of improving clinical outcomes and patient quality of life.
Additional information
Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Application: UpVagas lists this opportunity from the hiring company or its recruitment platform. The application is completed at the original source.
