Equipment Engineer

Job Description

The Equipment Engineer position is focused on process and equipment validation, troubleshooting, and continuous improvement of complex electromechanical systems. This role is ideal for someone who thrives in a fast-paced environment and enjoys hands-on work with production equipment from procurement through qualification and release.

• Own manufacturing and test equipment including robotic assembly systems, automated test equipment, calibration systems, and custom manufacturing fixtures.

• Lead equipment lifecycle activities including specification development, equipment selection, FAT/SAT, installation, commissioning, validation, and release to production.

• Plan and execute equipment validation activities including IQ/OQ/PQ protocols and support audit readiness through traceable documentation and validation evidence.

• Maintain compliant equipment documentation including URS, FRS, risk assessments, engineering drawings, preventive maintenance procedures, and change control records.

• Drive equipment reliability, uptime, yield improvement, and asset performance through preventive and predictive maintenance strategies.

• Lead root cause investigations, CAPA activities, and troubleshooting efforts for complex electrical, mechanical, pneumatic, robotic, and computer-controlled systems.

• Support manufacturing operations by resolving equipment issues while maintaining compliance with quality and regulatory requirements.

• Analyze equipment performance data and implement continuous improvement initiatives to reduce downtime and improve operational efficiency.

• Support internal and external audits, inspections, and quality investigations.

• Provide technical leadership and mentorship to technicians and junior engineers.

• Collaborate cross-functionally with Manufacturing, Quality, Regulatory, Validation, Supply Chain, and R&D teams to support production and new product introduction activities.

• Manage spare parts strategies, calibration programs, CMMS effectiveness, and equipment maintenance planning.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Bachelor’s degree in Engineering or equivalent combination of education and relevant experience.

• 4-8+ years of experience supporting capital equipment in manufacturing or regulated environments.

• Experience supporting automation, robotics, electromechanical systems, or custom manufacturing equipment.

• Working knowledge of GMP, FDA Quality System Regulations (QSR), ISO 13485, and change control processes.

• Experience supporting equipment validation activities including IQ/OQ/PQ.

• Experience leading equipment investigations, troubleshooting, and reliability improvements.

• Experience supporting audits, inspections, and quality investigations within regulated environments.

• Demonstrated ability to manage multiple priorities in a fast-paced production setting. • Experience within medical device, biotechnology, pharmaceutical, or highly regulated manufacturing environments.

• Experience with robotic assembly systems, automated inspection systems, or automated test equipment.

• Knowledge of design controls, risk management, and validation requirements.

• Experience leading capital equipment projects from concept through production release.