Equipment Engineer 1 (6:00am - 4:00pm Sat - Tue) # 4781

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.

You will work on-site full-time at our office located in Durham, NC

This position works the weekend shift, Sat - Tue from 6:00am to 4:00pm

Responsibilities:

• 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. 

Required Qualifications:

• 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)

Preferred Qualifications:

• 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.

Physical Demands and Work Environment:

• 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) is required when working on or near production equipment.

• Work may occasionally extend beyond regular hours to support maintenance or installation schedules.