Project Engineer

CQ Medical; Avondale (PA); On-site; USD 85,000 - 125,000; Full time

Job summary

CQ Medical is seeking an experienced design lead to drive development of electromechanical medical devices. You will own design control activities, create SolidWorks models and drawings, and guide projects from concept through transfer to production. Strong communication and regulatory awareness are essential.

The role emphasizes multi‑discipline collaboration, Design for Manufacturability, and active involvement in risk analyses, V&V, and design reviews to ensure robust, compliant products.

Qualifications

• Experience in product development and project management.
• Strong communication and leadership with customers and staff.
• Progression in product development with translating requirements.
• Excellent communication skills to interact professionally.
• Good organizational skills.
• Knowledge of manufacturing accounting.

Responsibilities

• Manage and execute design control activities.
• Lead project management and cross‑functional partner communications.
• Conceptualize mechanical design of medical device procedures and instruments.
• Create SolidWorks models and drawings per ASME Y14.5, ISO, and GD&T.
• Develop development documentation per FDA CFR 820.30 (specs, risk analyses, V&V).
• Transition new products into production.
• Support continuous improvement and regulatory compliance.
• Maintain Design History Files.
• Communicate status and issues with customers.

Skills

Product development

Project management

Leadership

Communication

Organizational skills

Manufacturing accounting

Education

Bachelor's degree in engineering

Master's degree

Tools

CAD (SolidWorks)

MS Office

MS Project

ERP software

Job description

• Responsible for managing and executing all design control activities.
• 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
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