Project Engineer

Position Summary

We are seeking a Contractor Project Engineer to lead and execute labeling update projects supporting the Project Engineering Department within a regulated medical device manufacturing environment. This role partners closely with Project Engineering, Quality, Regulatory Affairs, Operations, and other cross-functional teams to implement labeling changes, coordinate project activities, execute validation efforts, and ensure compliance with quality and regulatory requirements.

The specialist will be responsible for managing labeling-related change controls, assessing risks and compliance impacts, validating labeling equipment and systems as required, and driving projects from initiation through implementation and closure. The ideal candidate is a hands-on professional with strong project management, technical writing, problem-solving, and communication skills, along with a continuous improvement mindset.

Candidates must be proficient in English (written and verbal) and be available to support multiple shifts and weekend activities as business needs require.

Required Qualifications

- Bachelor’s degree in Industrial Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical discipline.

- Minimum of 5 years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments.

- Demonstrated experience leading and executing labeling update projects.

- Experience with change control processes and project lifecycle management.

- Experience validating labeling equipment, including printers, barcode systems, vision systems, and labeling software.

- Working knowledge of FDA Quality System Regulations (QSR), ISO 13485, ISO 9001, GMP requirements, or equivalent regulated environments.

- Experience creating and executing validation protocols and reports.

- Experience using Microsoft Project for planning, scheduling, tracking, and executing projects.

- Experience with Product Lifecycle Management (PLM) systems such as Agile PLM and ERP platforms such as Oracle or equivalent systems.

- Strong analytical, problem-solving, risk assessment, organizational, and technical writing skills.

- Strong verbal and written communication skills and ability to work effectively within cross-functional teams.

- Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Project.

- Ability to work in ISO Class 7 and Class 8 cleanroom environments while wearing required gowning for extended periods.

- Ability to support multiple shifts and weekends, as required by project and operational needs.

- Demonstrated initiative, accountability, adaptability, and commitment to continuous learning.