Design Assurance Engineer (Attleboro)

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. Masters 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.