Senior Development Quality Engineer

Senior Development Quality Engineer supporting Abbott's Electrophysiology division in Plymouth, Minnesota. This role leads design verification and validation activities for complex disposable catheter medical devices, manages multidisciplinary teams through product development phases, and ensures regulatory compliance with FDA and ISO standards.

Responsibilities

• Lead design characterization activities and holistic verification/validation strategies for development projects
• Train and mentor junior engineers while setting cross-functional team strategies for complex problems
• Conduct root cause investigations and corrective/preventive actions to identify underlying issues
• Manage design history file integrity, completeness, and regulatory compliance communications
• Represent organization during FDA and ISO regulatory inspections and external inquiries

Requirements

• Bachelor's degree in engineering or technical field
• Minimum 6 years new product development engineering experience
• Proficiency in design verification and validation techniques
• Applied statistics, sampling strategies, and design of experiments knowledge with tools like Minitab
• FDA, IEC 60601, GMP, ISO 13485, and ISO 14971 regulatory knowledge
• Medical device industry experience preferred
• Strong organizational skills and attention to detail