Supply Chain Operations – MES Technical Lead

Job Description:

Please note that this position is not available for visa sponsorship, and we are unable to take over existing employment visa sponsorships

POSITION SUMMARY

TransMedics is launching a major initiative to transform its Manufacturing Execution System (MES) operations, and we are seeking a hands-on Technical Lead to perform the technical and operational aspects of this effort. This is an individual contributor role with a strong focus on manufacturing operations technology, shop floor systems, and end-to-end production process orchestration. This role requires deep Critical Manufacturing MES platform expertise, strong technical integration skills, and a proactive approach to problem-solving. The ideal candidate will bring a strong manufacturing and production background, understanding of shop floor operations and equipment integration, deep knowledge of industrial IoT and regulatory compliance requirements, and the ability to bridge IT and manufacturing operations. This role will be instrumental in configuring and optimizing the MES platform, supporting integrations, and driving system testing and validation.

RESPONSIBILITIES

• Lead the technical execution of the MES transformation project, ensuring it is configured correctly and meets production operational requirements.

• Define and document technical configurations and integration requirements in collaboration with Manufacturing Operations, Production, and Supply Chain teams.

• Perform software configuration and system integration testing to ensure MES functionality and alignment with manufacturing workflows and business needs.

• Act as a technical MES expert, supporting platform configuration, customization, testing, and implementation.

• Collaborate with Manufacturing Operations to ensure MES capabilities meet shop floor requirements and production tracking needs.

• Support production, engineering, and quality teams in transitioning to the new digital manufacturing workflows and real-time data capture processes.

• Drive hands-on execution of system configuration, integration testing, validation, and production workflow mapping activities.

• Design and implement integrations between Critical Manufacturing MES and enterprise systems (ERP, QMS, PLM, etc).

• Configure shop floor data collection, equipment interfaces, and manufacturing process definitions within the Critical Manufacturing platform.

• Provide input into future MES governance structure and technical roadmap as the manufacturing technology function matures.

MANAGEMENT RESPONSIBILITIES

• No direct reports (This position will not have management responsibilities).

PHYSICAL ATTRIBUTES

• None (Standard office environment).                                                                            

MINIMUM QUALIFICATIONS                                                    

• Bachelor’s degree in Information Systems or related field.

• 5+ years of hands-on experience with Manufacturing Execution Systems, preferably with Critical Manufacturing platform.

• Strong understanding of manufacturing operations, production processes, and shop floor workflows in regulated industries (medical device, pharmaceutical preferred).

• Demonstrated experience with MES configuration, customization, and integration with enterprise systems (ERP, QMS, PLM).

• Experience with software testing, QA validation, and requirements documentation.

• Technical proficiency in system integration approaches including APIs, web services, and middleware platforms.

• Knowledge of FDA 21 CFR Part 11 and other regulatory requirements for electronic manufacturing records.

• Strong analytical and problem-solving skills with ability to translate manufacturing requirements into technical solutions.

• Excellent communication skills with ability to work effectively with both technical and operational stakeholders.

• Self-motivated with ability to work independently and manage multiple priorities in a fast-paced environment.

PREFERRED QUALIFICATIONS

• Direct experience implementing or supporting Critical Manufacturing MES platform.

• Experience in medical device or other highly regulated manufacturing environments.

• Knowledge of Industry 4.0 concepts, Industrial IoT, and smart manufacturing initiatives.

• Familiarity with data analytics and reporting tools for manufacturing intelligence.

• Experience with serialization, track and trace, and genealogy requirements.

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