Medical Device Project Engineer - Design & Validation Lead

Medtec LLC DBA CIVCO Radiotherapy; Avondale (PA); On-site; USD 75,000 - 110,000; Full time

Job summary

Medtec LLC DBA CIVCO Radiotherapy is seeking an experienced design engineer to drive medical device development, design control, and production transfer. You will lead mechanical design efforts, create GD&T drawings, and coordinate cross-functional teams to ensure compliant, deliverable products.

Responsibilities include vendor management, documentation, and DHF maintenance while aligning with regulatory requirements and continuous improvement initiatives.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Excellent communication and organizational skills.
• Experience translating customer requirements into practical designs.
• Familiarity with design controls and FDA CFR 820 compliance.
• Proficiency with SolidWorks and CAD software.

Responsibilities

• Manage and execute design control activities for medical devices.
• Lead vendor interactions and project documentation.
• Prepare design history files and design transfer activities.
• Conceptualize mechanical design and create GD&T drawings.
• Coordinate project planning and cross-functional communication.
• Support continuous improvement and regulatory compliance.

Skills

Project management

Communication skills

Team leadership

Organizational skills

Electromechanical design

Education

Bachelor’s degree in engineering

Master’s degree a plus

Tools

SolidWorks

MS Project

ERP software

Job description

Medtec LLC DBA CIVCO Radiotherapy is seeking an experienced design engineer to drive medical device development, design control, and production transfer. You will lead mechanical design efforts, create GD&T drawings, and coordinate cross-functional teams to ensure compliant, deliverable products.

Responsibilities include vendor management, documentation, and DHF maintenance while aligning with regulatory requirements and continuous improvement initiatives.