Design Assurance Engineer — Medical Devices

Stereotaxis, Inc.; Minneapolis (MN); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company is seeking a Design Assurance Engineer to support product development from concept to commercialization. This in-office role entails managing design process deliverables, collaborating on verification/validation protocols, and ensuring FDA compliance. Candidates should have at least 5 years of medical device experience and a Bachelor's Degree in Engineering. Strong project management and communication skills are essential for this position.

Qualifications

• Minimum 5 years medical device experience in manufacturing/quality/product development; catheter manufacturing preferred.
• Working knowledge of FDA/cGMP and MDD regulations/guidelines.
• Experience with all aspects of Risk Management throughout the lifecycle.

Responsibilities

• Manage deliverables from the design process including DHF and Engineering Project File documents.
• Collaborate with design engineers and technicians in developing verification/validation protocols.
• Lead the development of quality plan specific to each project.

Skills

Project management

Communication skills

Risk management

Verifications/validations

Education

Bachelor’s Degree/Technical Degree in Engineering

Tools

Quality Management System software

Job description

A leading medical device company is seeking a Design Assurance Engineer to support product development from concept to commercialization. This in-office role entails managing design process deliverables, collaborating on verification/validation protocols, and ensuring FDA compliance. Candidates should have at least 5 years of medical device experience and a Bachelor's Degree in Engineering. Strong project management and communication skills are essential for this position.