Lead Project Engineer

Job Title: Lead Project Engineer

Work Location: Wake County, North Carolina

Summary:

Seeking an experienced Lead Project Engineer to oversee the development, validation, and deployment of handheld clinical devices. This role requires strong technical leadership, hands-on engineering skills, and the ability to manage multiple workstreams in a regulated environment.

Responsibilities:

• Lead the selection, validation, and implementation of solutions for handheld clinical devices, ensuring all technical requirements are achieved.
• Act as the primary technical liaison with external software developers, overseeing code updates and ensuring compliance with relevant software standards.
• Independently update and maintain design specifications, risk management files, and design history documentation within electronic document management systems.
• Serve as the main point of contact with contract manufacturers, managing equipment transfer, materials logistics, and process readiness for manufacturing scale-up.
• Conduct hands-on bench testing, support device labeling, and prepare final kits for clinical study deployment.
• Ensure adherence to quality systems and regulatory requirements throughout all project phases.
• Coordinate equipment calibration and manage domestic shipping logistics as needed.
• Utilize advanced CAD tools and data management systems to support engineering and documentation processes.

Qualifications:

• Minimum of 10 years in multi-disciplinary engineering roles (Electrical, Mechanical, or Systems), specifically within the Medical Device industry.
• Experience working under ISO 13485 and revising IEC 62304 software documentation; ability to update Risk Management files (ISO 14971) with minimal supervision.
• Highly proactive, able to prioritize effectively, and work independently with minimal oversight.
• Hands-on engineer with strong mechanical aptitude and adaptability in evolving environments.
• Demonstrated ability to manage multiple complex workstreams, from lab testing to contract manufacturing, while maintaining attention to detail.
• Strong communication skills for effective collaboration with external partners, including contract manufacturers and software teams.
• Experience coordinating equipment calibration and domestic shipping logistics.
• Proficiency with electronic Document Management Systems (eDMS), formal Change Control processes, and advanced understanding of SolidWorks 3D CAD and PDM.
• Practical experience with precision measurement tools and structured data collection methods.

Published Category: Manufacturing & Technical Operations