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.

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)

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.

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.