MES SCO Technical Lead (Medical Device Industry)

WHO WE ARE

NextPhase.ai is a Data Management solution provider specializing in Data Operations services for enterprise cloud data, helping clients enhance data quality, strengthen governance, and achieve strategic business outcomes. As we expand into digital manufacturing and regulated industries such as medical devices, we continue to deliver innovative, high-value solutions that enable clients to focus on monetizing and scaling their data while we manage the complexity behind the scenes. We offer a dynamic, collaborative, and creative work environment where solving client challenges with smart, data-driven thinking is at the heart of what we do.

Overview

We are seeking an experienced MES SCO Technical Lead with strong expertise in digital manufacturing systems within the Medical Device industry. This role will drive the technical execution of a major MES transformation initiative, ensuring the Critical Manufacturing MES platform is configured, integrated, and validated to meet stringent production, quality, and regulatory requirements. The ideal candidate will bring hands-on MES experience, deep understanding of shop floor operations, and familiarity with medical device compliance standards.

Key Responsibilities

• Lead the technical execution of the MES transformation project, ensuring system configuration meets production, quality, and operational requirements specific to medical device manufacturing.
• Define, document, and validate MES technical configurations and integration requirements in alignment with Manufacturing Operations, Production, and Supply Chain teams.
• Perform MES software configuration, integration testing, and validation to ensure compliance with medical device regulatory expectations and manufacturing workflows.
• Serve as the technical MES subject matter expert supporting configuration, customization, testing, troubleshooting, and implementation activities.
• Partner with Manufacturing Operations to ensure MES capabilities support shop floor requirements, device history records, traceability, and production tracking needs.
• Support Production, Engineering, and Quality teams in transitioning to new digital manufacturing workflows and real-time data capture capabilities aligned with medical device regulations.
• Execute hands-on system configuration, integration testing, validation documentation, and production workflow mapping activities.
• Design and implement integrations between Critical Manufacturing MES and enterprise systems including ERP, QMS, PLM, and other systems critical to medical device manufacturing.
• Configure shop floor data collection, equipment interfaces, material flow definitions, and process routings within the Critical Manufacturing MES platform.
• Provide input into MES governance models and long-term technology roadmaps as the digital manufacturing function evolves within the medical device environment.

Management Responsibilities

• No direct reports; this is an individual contributor role with no formal management responsibilities.

Physical Attributes

• None; standard office / manufacturing conference environment.

Minimum Qualifications

• Bachelor’s degree in Information Systems, Computer Science, Engineering, or related field.
• 8 years of hands-on MES experience—Medical Device or Pharmaceutical industry required.
• Experience with Critical Manufacturing MES strongly preferred.
• Strong understanding of manufacturing operations, production processes, and shop floor workflows in the medical device industry, including traceability, DHR/DHF, and validation.
• Demonstrated experience with MES configuration, customization, and integration with enterprise systems such as ERP, QMS, and PLM.
• Experience with software testing, validation (IQ/OQ/PQ), and requirements documentation in regulated environments.
• Technical proficiency with APIs, web services, integration middleware, data interfaces, and automation technologies.
• Solid understanding of FDA 21 CFR Part 11, ISO 13485, and other regulatory requirements for electronic manufacturing records and data integrity.
• Strong analytical and problem-solving skills with the ability to translate medical device manufacturing needs into scalable MES solutions.
• Excellent communication and interpersonal skills, with experience collaborating across technical, operational, and quality functions.
• Self-motivated and able to manage multiple priorities in a fast-paced, highly regulated environment.

Preferred Qualifications

• Direct experience implementing or supporting the Critical Manufacturing MES platform in a medical device setting.
• Experience working in regulated, compliance-heavy manufacturing operations (Class I, II, or III medical devices).
• Knowledge of Industry 4.0, IIoT, automation, and smart manufacturing enablement.
• Experience with data analytics, dashboards, and reporting tools used for manufacturing intelligence.
• Familiarity with serialization, UDI, genealogy, and traceability requirements for medical device products

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.

NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.