Job Description

Key Qualifications

• Must be a US Citizen / green card holder
• Must have DESIGN CONTROL and MEDICAL DEVICE experience
• Bachelors in Bioengineering, Biomedical, Mechanical Engineering, or a related field is required. Master’s degree is preferred
• Minimum 3 years of experience with direct client interactions, product demonstrations.
• Minimum 5 years of experience in design controls, risk management, and quality engineering.
• Proficiency in CAD software and statistical analysis tools.
• Strong knowledge of regulatory requirements (FDA, ISO 13485, ISO 14971).
• Experience with CAPA systems, audits, and validation requirements.
• Expertise in design verification and validation methodologies.
• Familiarity with quality management systems (QMS) and failure analysis techniques.
• Knowledge of Design for Manufacturing and Assembly (DFMA) principles.
• Experience with reliability engineering, geometric dimensioning and tolerancing (GD&T), and industry-specific standards.

Technical Competencies

• Quality control standards and methodologies.
• Quality assurance software and tools.
• Design control principles and risk management.

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