Job Description

PURPOSE OF JOB

Purpose of this position is to provide process and automation engineering leadership in

meeting plant's operational objectives. He should provide engineering support for value

stream manufacturing operation, lead automation projects, process validation,

troubleshooting equipment and project management.

JOB FUNCTION

. Lead Process engineering team to ensure seamless support to the value stream

in meeting their respective objectives.

. To lead the engineering initiatives to ensure optimal machine up-time is available

for production.

. Lead automation projects including equipment upgrade and assembly process

productivity initiatives.

. Lead and manage engineering efforts that are needed to improve yield, output

and quality. Ensure the PM and calibration activities are done as per the

schedule

. Provide engineering expertise in achieving equipment reliability and process

capability to achieve desired OEE metrics.

. Manage optimal deployment of engineering resources and efficient use of the

budget.

. Lead the validation activities and projects by providing necessary engineering

support and resources.

. Plan and execute equipment maintenance/upgrade by embarking on structured

equipment risk assessment and prioritization.

. Work with cross functional teams (Techteam) to achieve equipment

effectiveness through total productive maintenance program and process

capability through process enhancement and validation.

. Work with team to execute continuous improvement projects to minimize

operational disruption and achieve productivity savings.

. Accountable for capital expenditure initiation and spending control

. Ensure compliance with quality policies,procedures, and practices through

appropriate communication, training, and education.

. Maintain a safe and healthy work environment by complying with all related

safety regulations and environmental policies in the Company

INTERACTION

Internal parties:

. Required to communicate effectively with all levels of associates.

External parties:

. Required to communicate with other Merit Medical Plants, Corporate / Regional/Businesses, suppliers subcontractors and government agencies as and when required.

JOB SPECIFICATIONS

Education:

Bachelor's degree in mechanical engineering, Electrical Engineering, Material Science, or a related discipline, with 5-10 years of hands-on experience in automation and automated assembly processes. Experience in automation is required. Preferably from the Medical Device or Pharmaceutical industry.

Relevant Experience:

Strong hands-on experience in automation, automated assembly processes, and the design/development of tooling and fixtures is required.

Proven track record of leading automation projects from concept to implementation, including equipment qualification and process validation.

Working knowledge of cGMP manufacturing environments.

Others:

Technical expertise in automation systems, assembly process optimization, robotics, and manufacturing automation is essential.

Knowledge of U.S. FDA regulations, Medical Devices Regulation (EU 2017/745), ISO 13485 Quality System Standard, and ISO 14971 Risk Management is an added advantage.