Design Quality Engineer

We are hiring for our client, a leading organization in the medical device industry, seeking a Design Quality Engineer to join their team. This is a strategic and hands-on role responsible for ensuring quality and regulatory compliance throughout the product development lifecycle. The ideal candidate is an experienced engineering professional with deep expertise in design controls, risk management, and quality assurance, and thrives in client-facing environments.

Responsibilities

• Oversee product development projects with emphasis on design controls, risk management, and regulatory compliance.

• Manage client interactions and project execution from planning through delivery.

• Lead risk management activities (FMEA, fault tree analysis, ISO 14971).

• Ensure compliance with FDA (21 CFR 820), ISO 13485, ISO 14971, and related design control standards.

• Review and approve design documentation, including DHF and RMF.

• Collaborate with R&D, regulatory, quality, and manufacturing teams.

• Support design reviews, validation processes, and usability analysis (IEC 62366).

• Monitor regulatory updates and revise internal procedures accordingly.

• Conduct audits and inspections of design processes and procedures.

• Champion continuous improvement initiatives in the design department.

• Mentor and coach junior engineers and technicians.

• Manage complaint systems and address post-release safety risks.

• Develop and implement quality control plans and risk management processes.

• Prepare and present design quality performance reports to management.

Qualifications

• Bachelor’s degree in Bioengineering, Biomedical, Mechanical Engineering, or a related field required; Master’s degree preferred.

• Minimum 5 years of experience in design controls, risk management, and quality engineering.

• At least 3 years of experience in direct client interactions and product demonstrations.

• Proficiency with CAD software and statistical analysis tools.

• Strong knowledge of regulatory requirements (FDA, ISO 13485, ISO 14971).

• Experience with CAPA systems, audits, and validation processes.

• Expertise in design verification, validation methodologies, and QMS.

• Familiarity with DFMA principles, reliability engineering, and GD&T.

• Knowledge of failure analysis techniques and industry-specific standards.

Competencies & Skills

• Strong technical background in quality control standards, methodologies, and assurance tools.

• Expertise in design control principles, risk management, and SPC methods.

• Problem-solving methodologies (Six Sigma, Lean).

• Ability to lead usability engineering and design review processes.

• Exceptional communication and client-facing skills.

• Proven leadership and mentoring capabilities.