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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.
Every Organ Wasted is a Life Not Saved.
TransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. Our mission is to help save more patients’ lives by increasing access to viable donor organs for those who are awaiting an organ transplant. To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes.
Driven by a passion for improving patient care, we make the impossible possible and keep our employees at the center of everything we do. Together, we strive to enhance the quality of life for transplant recipients and their families, fostering hope and healing in the journey toward better health.
Maximize your potential at TransMedics, Inc.
TransMedics is committed to equitable and transparent compensation. The expected base salary range for this role is $132,150.00- $164,850.00, which represents the company’s current good-faith estimate of compensation for this position. Actual salary will depend on factors such as, but not limited to, candidate experience, qualifications, skills, and the specific work location. This role may also be eligible for bonuses, equity, and a comprehensive benefits package (medical, dental, vision, retirement savings, paid time off, and wellness resources). We comply with all U.S. pay transparency laws and do not request or consider salary history.
Employee Benefit:
TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.
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