What are the responsibilities and job description for the Design Assurance Engineer II position at Sci.bio Recruiting?
We are seeking a Design Assurance Engineer II to serve as the key QA partner on product development projects from concept through manufacturing transfer. In this role, you will lead core Design Assurance activities, support risk management, and drive product improvements through cross-functional complaint investigations, metrics and data analysis, and CAPA management.
Job Responsibilities
- Lead Design Assurance activities for new product development (risk management, V&V planning and execution, statistical analysis, design reviews, and R&D testing)
- Drive product improvements through cross-functional complaint investigations and root cause analysis
- Support complaint metrics and data visualization (Excel, Tableau)
- Manage and execute CAPAs
- Review document and design changes
Required Skills & Qualifications
- Minimum of 3-5 years of experience in design assurance/engineering roles within the medical device industry.
- Experience with risk management methodologies (e.g., FMEA, fault tree analysis) and risk management tools.
- Solid computer skills essential, including Microsoft Office Suite, Adobe, Minitab, etc.
- Comfortable with basic statistics and data analysis
- Knowledge of FDA regulations and ISO 13485 standards for medical devices
- Experience with project management is a plus
Salary : $70,000 - $100,000