What are the responsibilities and job description for the Design Assurance Engineer position at ExecutivePlacements.com?
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.
- Quality control standards and methodologies.
- Quality assurance software and tools.
- Design control principles and risk management.
