Equipment Engineer Sun - Wed

Job Summary

The Equipment Engineer I contributes professional engineering support to the evaluation, installation, modification, and maintenance of manufacturing equipment to ensure reliable, efficient, and compliant operation. Operating within a professional scope, this role applies foundational engineering principles to assess equipment performance, support technical problem‑solving, and participate in improvement initiatives that strengthen equipment reliability and operational consistency. The position collaborates with engineers, technicians, and cross‑functional partners to advance technical solutions, maintain engineering documentation, and contribute to the effective execution of equipment engineering activities.

Location:

On‑site full‑time at our office in Durham, NC.

Schedule:

Weekend shift, Saturday–Tuesday from 6:00 am to 4:00 pm.

• Performs engineering analyses by collecting data, reviewing operational trends, and preparing technical observations to support evaluations of equipment performance and reliability.
• Supports professional engineering activities related to installation, modification, and qualification of manufacturing equipment, ensuring alignment with established engineering standards and production requirements.
• Executes advanced maintenance, repair, and technical adjustments on complex manufacturing equipment by applying extensive procedural knowledge and hands‑on expertise.
• Contributes to equipment troubleshooting efforts by applying engineering principles to initial assessments and collaborating on the development of corrective actions and process improvements.
• Develops and maintains engineering documentation, including specifications, change records, technical instructions, and performance logs, ensuring accuracy and compliance with engineering controls.
• Collaborates with engineers, maintenance personnel, and operations teams on continuous improvement initiatives that enhance equipment capability, efficiency, and reliability.
• Participates in equipment testing, calibration, and verification activities to support engineering evaluations and adherence to technical standards.
• Applies professional judgment within defined engineering procedures while upholding safety, quality, and regulatory requirements in all aspects of equipment engineering support.
• These responsibilities summarize the role’s primary responsibilities and are not an exhaustive list. They may change at the company’s discretion.

• Bachelor’s degree in mechanical engineering, electrical engineering, manufacturing engineering, or a related technical discipline.
• 0–2 years of relevant engineering experience, preferably in a manufacturing or production environment.
• Basic understanding of mechanical, electrical, pneumatic, and control systems.
• Familiarity with CAD tools, technical drawings, and engineering documentation.
• Knowledge of root cause analysis methods and problem‑solving techniques is preferred.
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:
• GMP quality management systems (e.g., ISO 13485)
• Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
• Operations within the regulated medical device environment (e.g., IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)

• Analytical mindset with strong problem‑solving and technical reasoning abilities.
• Ability to learn and apply engineering concepts to practical manufacturing challenges.
• Effective communication and collaboration skills across technical and operations teams.
• Attention to detail and accuracy in documentation and data analysis.
• Commitment to safety, quality, and continuous improvement principles.

• Works primarily in a manufacturing and engineering environment with regular exposure to production areas, equipment, and occasional noise.
• May require standing, walking, and occasional lifting during equipment inspections or installations.
• Use of personal protective equipment (PPE)…