Leads process engineering support for medical device manufacturing, including automation projects, equipment upgrades, maintenance, calibration, validation, and continuous improvement. Improves machine uptime, yield, output, quality, process capability, and OEE while managing engineering resources, capital expenditures, risk assessments, and compliance. Collaborates with production, technical teams, suppliers, plants, and regulatory stakeholders to maintain safe, efficient, and compliant operations.
Work Shift:
DAYWork Schedule:
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
JOB FUNCTIONS
- 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.
To see more on our culture, go to www.merit.com/careers.
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