Project Engineer

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

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for managing and executing all design control activities.
• Manage vendor interaction for projects.
• Maintain project documentation.
• Team liaison with other Company functions.
• Strong, hands-on involvement with all phases of medical device development.
• Conceptualization and primarily mechanical design of medical device procedures, instruments, and devices using fundamental engineering knowledge and principles.
• Solid modeling via SolidWorks of design concepts and creation of design drawings using ASME Y14.5, ISO, and GD&T principles.
• Creation of development documentation consistent with FDA CFR 820.30, such as product specifications, risk analyses, verification/validation reports, etc.
• Participate in and/or lead project management activities such as regular planning events, partner communications, and resource coordination.
• Develop and leverage working knowledge of relevant manufacturing processes to apply Design for Manufacturability.
• Designing, executing, and analyzing experiments, verification tests, and validation tests using statistical techniques and publish associate reports.
• Conduct basic market and intellectual property research.
• Maintain Design History Files in accordance with established procedures.
• Participate and lead in design review and design transfer activities.
• Transition new products into production.
• Participate, as needed, in efforts associated with continuous improvement, regulatory compliance, and other organizational capability initiatives.
• Build and maintain effective communication and relationships with internal and external customers regarding status, timing and design issues impacting the project.
• Background in Electromechanical with automated systems experience.

QUALIFICATIONS

• Experienced product developer and project manager.
• Professional, polished demeanor, capable of leading discussions and ideation sessions with customers and internal staff members, comfortable interfacing with all levels of the organization.
• Demonstrated career progression through the product development ranks with an emphasis on translating customer requirements to practical designs.
• Candidate must possess excellent communication skills to maintain a professional attitude with all internal and external customers relating to this position.
• Good organizational skills.
• Good understanding of accounting in a manufacturing environment.

EDUCATION and/or EXPERIENCE

• Experience using MS Office, Outlook, MS Project, or other Gantt Chart Software.
• Experience using accounting and ERP software.
• Experience using CAD software, SolidWorks a plus.
• Bachelor’s degree from four-year college or university in a related engineering field; or one to two years related experience and/or training in a similar position; or equivalent combination of education and experience. Master’s Degree a plus.
• Electromechanical experience a plus.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.