Staff Automation Engineer - Validation

Dexcom

Athenry, Ireland

Meet the team:

You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures and automation houses. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the qualification, validation and change management of complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes. You will ensure high efficiency, precision, and quality in our operations. You will play a pivotal role in ensuring robust new product introduction, capacity expansions, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle.

Where you come in:

You will lead and collaborate with internal and external cross-functional teams supporting the validation strategy development and implementation for product assembly equipment, system architecture, robotics concepts, and tooling.
You will conduct feasibility studies, testing new and modified designs, and analyze mechanical systems and equipment to drive greater yield, performance, and quality.
You will develop test plans, equipment requirements, protocols, and reports to ensure designs meet product specifications, regulatory requirements, and standards for new equipment and processes, including IQ/OQ/PQ protocols.
You will author and support the execution of equipment acceptance testing (FAT/SAT) and validation protocols (IQ/OQ/PQ) and reports for new or modified production equipment at contract manufacturing partners. Assist in protocol execution as needed.
You will play a key role in change management assessment and any validation requirements for on-market equipment improvement or other change management projects, ensuring comprehensive documentation and timely communication, and assure quality and regulatory compliance is maintained.
You will review and analyze daily contract manufacturing production data, implementing strategies to enhance output and efficiency of equipment performance.

What makes you successful:

You have proficiency in automation and validation processes (IQ/OQ/PQ/TMV). You possess the ability of translating user requirements into validation deliverables.
You are experienced in developing and executing validation strategies for complex automation, including authoring of documentation and date review. You can create efficient strategies to drive speed to implementation for new and replicate equipment without compromising quality or compliance.
You collaborate for URS development & design reviews of all control aspects of the development of an automated system.
You understand the quality and regulatory compliance requirements for product manufacturing automation for high-volume Class II medical devices.
You possess exceptional problem-solving and analytical skills, with the ability to interpret complex data and make informed decisions.
You can work effectively in a team environment, collaborating with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance to achieve common goals.
You effectively communicate with internal teams and external partners. This includes conveying technical concepts clearly, providing timely updates, and fostering collaborative relationships to ensure alignment and successful project outcomes.
You contribute to the innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. You support the identification and implementation of technology and process solutions to enhance performance and achieve both short-term and long-term objectives.

Key Competencies:

Expertise in regulatory requirements and standards such as FDA 21 CFR Part 11, and ISO standards. This includes the ability to develop and execute validation protocols (IQ/OQ/PQ) to ensure compliance.
Bachelor’s degree in mechanical engineering or related field.
Possesses hands-on experience with high volume automation assembly machines from development to qualification through to on-market continuous improvement and change management.
Experience in statistical process control (SPC) and use of software tools such as Minitab or JMP for data analysis, process troubleshooting and optimization.
Proficiency in SolidWorks, dimensional tolerancing and GD&T Standards.
Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, and Six Sigma methodologies to significantly enhance equipment efficiency, reduce operational costs, and elevate product quality standards.