Prin Manufacturing Engineer.

Careers that Change Lives - onsite daily at our Danvers facility

This position is a key role at site level at start, during and post deployment of the MES system, the role requires strong manufacturing process knowledge combined with industrial data and Operational Technology knowledge.

This is a hands-on role and requires deep knowledge of the MES system.The aim of the role is to assure local ownership of the MES system with the objective to become self-sustaining.

The MES owner is the core site experts that assures smooth transition of current as-is process to future to-be processes according to GxP.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

The go to person at site level for everything related to Manufacturing Execution System (MES). Overall, the Site MES Owner plays a critical role in ensuring the successful deployment, operation, and optimization of the MES system at the manufacturing site, ultimately contributing to improved efficiency, productivity, and quality within the organization.

Facilitates collaboration between Core and Deployment Teams. Obtains formal acceptance / sign-off when necessary.

Working closely with stakeholders across different departments to gather and document requirements for the MES system. This includes understanding business needs, user requirements, and technical specifications to ensure alignment with site-specific objectives.

Overseeing the configuration and customization of the MES system to meet site-specific requirements. This may involve defining workflows, configuring user interfaces, and integrating with other systems and equipment within the manufacturing environment.

Complete the maintenance plan and report. Review and approve scenarios, as well as conduct regression testing. Load and review user acceptance testing results into the QMS for validation. 3

Ensuring that site personnel are adequately trained on using the MES system effectively. This includes developing training programs, conducting user training sessions, and providing ongoing support to facilitate smooth adoption of the system.

Monitoring the performance of the MES system to ensure that it meets site objectives for productivity, efficiency, and quality.

This involves analyzing system metrics, identifying areas for optimization, and implementing improvements to enhance system performance.

Ensuring that the MES system complies with relevant industry standards, regulations, and quality management requirements.

This may involve conducting audits, maintaining documentation, and implementing controls to ensure regulatory compliance.

Facilitating change management processes associated with the MES deployment, including communicating changes and key decisions to site personnel, addressing concerns, and promoting acceptance of the new system.

Driving continuous improvement initiatives to optimize the use of the MES system and maximize its value to the organization.

Serving as the primary point of contact for communication and coordination between stakeholders involved in the MES deployment.

This includes providing regular updates, facilitating meetings, and addressing concerns raised by stakeholders.

Driving standardization relating to MES System and business processes

Aligning with other global plant deployment teams to drive standardization relating to MES system and business processes.

Must Have : Minimum Requirements

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have

Strong expertise of current manufacturing processes, information flows, material flows, production flows, critical data collection points

Ideally MES experience gained in previous deployments.

Strong computer literacy and passionate about digitalization

Experience in Microsoft office tools like powerpoint / visio

Project management skills

Communication and influence skills

Written communication skills

Presentation skills

Knowledge of product development, manufacturing, clinical, regulatory and business management requirements

PC skills; word processing, project management, and spreadsheet software.

Knowledge of medical device industry

Macintosh, Microsoft word and project management and Excel

Experience leading project teams

7+ years technical experience in a manufacturing industry with BS or 5+ years technical experience in a manufacturing industry with MS

Project management experience

MBA or MS in engineering