Senior Process Engineer

Senior Process Engineer

Dexcom

Athenry, Ireland

Our Engineering team is looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As a Senior Process Engineer, you will use sound and proven engineering principles in the implementation, characterization, improvement, and qualification/validation of manufacturing processes for replicate manufacturing equipment used in the scale-up of new or existing products.

Where you come in:

• You will be responsible for Installation, Commissioning, and Validation of processes within Manufacturing.
• You will be responsible for all sustaining activities to ensure core Operations KPIs (Yield, Performance, Availability, etc.) are met/exceeded.
• You will be responsible to for all continuous improvement initiatives and process improvement projects.
• You will support on training to news hires including Manufacturing Associates/Product Builders, Technicians and Engineers.
• You will lead and execute the Equipment/Process Qualifications including IQ, OQ, PQ as well as PPQ.
• You will lead the spares management including critical spares, End of Life Component planning and all relevant activities for maintaining the Equipment.
• You will develop and maintain project timelines and provide updates and feedback to project leadership.
• You will implement problem solving skills and techniques to identify potential process risks, assess their impact developing and implementing mitigation plans.
• You will plan and perform Design of Experiments (DOE) and utilize six sigma methodologies to characterize, assess capabilities, and determine optimal processing operating windows.
• You will consult with vendors to produce equipment, materials, and/or parts that meet determined product specifications.
• You will perform statistically robust and industry standard analysis of data, and present findings to technical teams.
• You will transfer process knowledge and understanding to receiving site operations teams along with providing technical training for responsible processes.
• You will consult with Global Engineering and other relevant Global Teams in scaling up equipment.
• You will assume and perform other duties as assigned.

What makes you successful:

• You have experience supporting the qualification/validation of automated manufacturing equipment.
• You have knowledge of control systems, HMIs, sensor technologies, servo drive systems, and machine vision within automated manufacturing environments.
• You have the ability to adapt to fast moving and changing environments
• You have excellent technical problem solving and risk management skills.
• You are detail oriented with ability to multi-task and maintain a strong focus on quality and accuracy.
• You have strong technical leadership and collaborative skills required.
• You have strong interpersonal and communications skills, both verbal and written.
• You are familiar with PLC systems in a manufacturing setting.
• You have the ability to travel to other supplier and/or manufacturing sites, if necessary.

Nice to have:

• You have experience programming or interfacing with robotic systems.
• You have experience in medical device high volume manufacturing.
• You have a strong understanding of risk management policies and procedures associated with medical device manufacturing.
• You have six Sigma training and Belt certification.

Education & Experience:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years of experience.