Associate 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 Diploma in mechanical/electrical with 3 to 5 years experience in manufacturing process environment.

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.