Process Engineer

• 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 (Tech team) 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 Plants, Corporate / Regional/Businesses, suppliers, subcontractors and government agencies as and when required.

JOB SPECIFICATIONS

Education: 􀁸

• Minimum Degree in mechanical / Electrical engineering/ Material Science with 5-10 years’ experience in automation and assembly processes. Preferably from Medical device / Pharmaceutical industries.

Relevant Experience: 􀁸

• Familiarization with assembly process, automation, tooling & fixtures designs are desired.􀁸 Experience in project management; as well as validation are preferred. 􀁸 Working knowledge on cGMP manufacturing setting

Others: 􀁸

• Technical specialization in assembly/ automation process preferred.

• 􀁸 Knowledge of U.S FDA regulations, the Medical Devices Regulation (2017/745), ISO 13485 Quality System

Standard, ISO 14971 Risk Management are added advantage.

• 􀁸 Knowledge of U.S FDA regulations, the Medical Devices Regulation (2017/745), ISO 13485 Quality System

Standard, ISO 14971 Risk Management are added advantage.