Design Quality Engineer

Excelon Solutions; Raritan (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Excelon Solutions is seeking a Design Quality Engineer to drive quality and regulatory compliance for medical device programs in New Jersey. The role emphasizes hands-on leadership in design controls, CAPA, risk management, and audits.

You will lead DHF reviews, approve verification/validation deliverables, and participate in design reviews to ensure product and regulatory readiness. The position requires strong experience with ISO 13485 and US/EU medical device regulations.

Responsibilities

• Hands-on experience in medical device design and development.
• Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
• Hands-on experience in Component Qualification and Process Validation activities.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product, process, and supplier changes for quality and regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.

Job description

• Hands-on experience in medical device design and development.
• Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD).
• Hands-on experience in Component Qualification and Process Validation activities.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and ISO 14971 Risk Management.
• Lead and maintain Risk Management Files including Hazard Analysis and FMEAs.
• Review and approve DHF deliverables and quality documentation.
• Review and approve verification, validation, and design transfer deliverables.
• Participate in Design Reviews to ensure quality, regulatory, and product requirements are met.
• Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies.
• Assess product, process, and supplier changes for quality and regulatory impact.
• Participate in CAPA, and nonconformance investigations.
• Analyze quality metrics and complaint trends to drive continuous improvement.
• Serve as a Design Quality SME during audits, inspections, and design reviews.