Medical Device Project Engineer: Design & Validation

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

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.