Senior Design Assurance Engineer

Senior Design Assurance Engineer role to support new product development, ensuring desired design performance, and meeting regulatory requirements. The role involves leading cross-functional teams, risk management, and usability program activities.

Requirements

• Bachelor's Degree in Engineering or related field
• 7-10 years of experience
• Practical knowledge of FDA Quality System Regulations, ISO 13485, and Medical Device Directive
• General familiarity with industry best practices in development, testing, and manufacturing processes
• Demonstrated proficiency in statistical methods and quality lean sigma tools

Benefits

• Comprehensive benefits package
• Cash-based incentive program
• 80 hours (10 days) of company designated holidays per year
• Annual allotment of paid time off
• 401(k) plan with company matching contributions
• Parental leave after one year
• Medical, dental, vision, disability, life insurance, and adoption benefits