Jobs · Management · North Carolina

Equipment Engineer 1 # 4781 (6:00am - 4:00pm Sun - Wed)

BioSpace · Durham, NC · 4 wk ago
Management$69k–$85k/yrFull-time

About the role

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.

Responsibilities

  • Performs engineering analyses by collecting data, reviewing operational trends, and preparing technical observations to support evaluations of equipment performance and reliability.
  • Sustains 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.

Requirements

  • 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)

Qualifications

  • An 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.
  • A commitment to safety, quality, and continuous improvement principles.

Skills

  • Strong problem-solving and technical reasoning abilities.
  • Effective communication and collaboration skills.
  • Attention to detail and accuracy in documentation and data analysis.
  • A commitment to safety, quality, and continuous improvement principles.

Benefits

  • Comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies.
  • This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.

Pay

The expected, full-time, annual base pay scale for this position is $69,000 - $85,000. Actual base pay will consider skills, experience, and location.

Schedule

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

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