Design Assurance Engineer

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

Company Description

Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.

Position Summary

The Design Assurance Engineer directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product.

Essential Responsibilities

• Manage deliverables from the design process including DHF and Engineering Project File documents.
• Collaborate with design engineers and technicians in the development of verification/validation protocols.
• Participate on design teams to assure product requirements as well as quality requirements are documented and addressed.
• Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
• Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
• Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
• Lead the development of quality plan specific to each project.
• Assist with the development of inspection processes and equipment including test fixtures.
• Train company employees on Quality related activities.
• Other duties as assigned.

Qualifications & Skills

• Bachelor’s Degree/Technical Degree in Engineering.
• Minimum 5 years medical device experience in manufacturing/quality/product development; catheter manufacturing and development preferred.
• Working knowledge of FDA/cGMP and MDD regulations/guidelines, and International Standards.
• Experience with design verifications/validations.
• Experience with all aspects of Risk Management throughout the lifecycle.
• Experience with Quality Management System software.
• Must possess good project management skills and initiative in taking on and completing projects.
• Strong verbal and written communication skills.
• Must be able to manage and prioritize multiple projects/objectives.
• Legally authorized to work in the United States.

Work Conditions

This role is an in-office position at Stereotaxis’ Rogers MN facility.

Culture

Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.