Senior Design Assurance Engineer

Overview

The Senior Design Assurance Engineer at Imricor Medical Systems Inc plays a critical role in supporting product development and ensuring the highest quality of medical devices. This role involves collaboration across Engineering, Operations, Quality Systems, and Regulatory teams to secure a successful production launch and maintain rigorous quality control.

Key Responsibilities

• Execute and support product development deliverables.
• Create and maintain Design History File (DHF) to meet regulatory standards.
• Develop customer and product requirements, specifications, and risk management documentation.
• Author design verification/validation plans and reports.
• Implement sampling inspections, qualification activities, and test method validations.
• Utilize statistical techniques for testing and root cause analysis.
• Support quality system deliverables including nonconformances and CAPAs.

Qualifications & Requirements

• Bachelor of Science in Engineering required.
• Minimum 5 years’ experience in Engineering or Quality in the medical device industry.
• Advanced knowledge of Quality Systems and documentation practices.
• Experience with design controls, test method validation, and corrective actions.
• Familiarity with FDA 21 CFR, European Medical Device Regulations, ISO 14971, and ISO 13485.

Working Conditions

This role is based in Burnsville, MN and requires light physical work, minimal travel (<10%), and compliance with environmental, health, and safety policies.

Key skills/competency

• Design Assurance
• Quality Systems
• Medical Devices
• DHF
• Risk Management
• Design Verification
• Design Validation
• Regulatory Compliance
• Statistical Analysis
• CAPA