Associate Design Quality Engineer – Medical Devices

Zimmer Biomet; Englewood (CO); On-site; USD 50,000 - 70,000; Full time

Job summary

Paragon 28 (a Zimmer Biomet company) in Englewood, CO is seeking an Associate Quality Engineer - Design to safeguard product excellence and patient safety. You will work hands-on across design, manufacturing, and supply chain to ensure compliant, reliable devices.

This role emphasizes collaboration on quality systems, regulatory controls, risk management, and supplier interaction, with a focus on supporting design transfers and validation activities.

Qualifications

• Bachelor’s in engineering or a technical discipline.
• Familiarity with 21 CFR 820 and ISO 13485.
• Knowledge of Medical Device Design Controls preferred.
• Technical writing skills that include QMS procedures.
• Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Machining methodologies and materials experience helpful for supplier communication.

Responsibilities

• Provide quality engineering support on new products and processes.
• Support manufacturing with quality metrics, sample plans, and inspection methods.
• Address non-conforming product issues and drive CAPA investigations.
• Perform inspections using standard inspection equipment.
• Assist in design controls per FDA QSR, EU MDR, ISO 13485 and other applicable ISO/EN standards.
• Participate in ISO 14971 risk management activities.
• Assist in supplier qualification and interface with suppliers.
• Support verification and validation protocols, testing, and test reports.
• Assist in Design Control and Transfer for new product development projects.
• Prepare procedures, plans, protocols, and reports to ensure regulatory compliance.
• Represent quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP).
• Other duties as assigned

Skills

Quality engineering

GD&T knowledge

Regulatory knowledge (FDA 21 CFR 820;

Technical writing (QMS)

MS Office

Education

Bachelor's degree in engineering or technical discipline

Tools

SAP

Job description

Paragon 28 (a Zimmer Biomet company) in Englewood, CO is seeking an Associate Quality Engineer - Design to safeguard product excellence and patient safety. You will work hands-on across design, manufacturing, and supply chain to ensure compliant, reliable devices.

This role emphasizes collaboration on quality systems, regulatory controls, risk management, and supplier interaction, with a focus on supporting design transfers and validation activities.