Equipment Engineer 2 #4778, #4779 (Night Shift 10:00pm - 8:00am, Wed - Sat)

Responsibilities:

• Conducts professional engineering analyses to assess equipment performance, identify reliability concerns, and develop data-driven recommendations for improvement.

• Supports the installation, modification, and qualification of laboratory manufacturing equipment by applying engineering principles and collaborating with technicians, engineers, and operations teams.

• Executes advanced maintenance, repair, and technical adjustments on complex manufacturing equipment by applying extensive procedural knowledge and hands-on expertise

• Applies structured problem-solving methods to troubleshoot equipment issues, develop corrective actions, and implement improvements that strengthen equipment reliability.

• Develops, updates, and maintains engineering documentation, including technical specifications, process instructions, test results, and change records, in accordance with engineering controls.

• Collaborates with cross-functional partners on continuous improvement initiatives, contributing engineering insights that enhance equipment capability, throughput, and performance.

• Supports preventive and predictive maintenance programs by evaluating equipment behavior, reviewing failure data, and recommending engineering-driven reliability enhancements.

• Performs engineering-level testing, calibration, and verification activities to ensure equipment accuracy and compliance with quality and safety standards.

• Exercises professional judgment within established engineering practices to ensure safe, compliant, and efficient operation of manufacturing equipment.

• 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 related discipline.

• 2 + years of relevant experience in equipment engineering, manufacturing, or maintenance engineering, or a master’s degree with 0–2 years of experience.

• Demonstrated knowledge of automated manufacturing systems, control systems, and process instrumentation.

• Proficiency in reading and interpreting mechanical and electrical drawings and schematics.

• Familiarity with root cause analysis and failure mode and effects analysis (FMEA) tools.

• 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:

• Strong problem-solving skills with the ability to diagnose complex equipment and process issues.

• Analytical and data-driven approach to process improvement and decision-making.

• Effective collaboration and communication skills across technical and operational teams.

• Ability to manage multiple assignments and adapt to changing priorities in a fast-paced environment.

• Commitment to quality, safety, and operational excellence.

Physical Demands and Work Environment

• Works in a manufacturing and engineering environment with frequent exposure to production equipment, machinery, and moderate noise.

• May require hands-on support in production areas, including standing, bending, or lifting equipment components.

• Use of personal protective equipment (PPE) is required per safety and compliance standards.

• May occasionally require overtime or off-shift support to address critical maintenance or project activities.