Quality Sr Engineer I

Zimmer Biomet seeks a Quality Senior Engineer I to support product development and design assurance for medical devices. The role involves managing design history file deliverables, coordinating verification and validation activities, and partnering across engineering, marketing, and operations teams.

Responsibilities

• Partner with marketing, clinical, R&D, and operations on product development and design improvements
• Develop and review design history file deliverables for hardware, software, and integrated systems
• Write verification and validation protocols, test procedures, and technical reports
• Drive risk management activities including analysis and human factors studies
• Coordinate manufacturing launch of new or revised products with team training and evaluation

Requirements

• Bachelor's degree in engineering
• 5+ years product development experience in software and capital systems, quality-focused
• 3+ years software quality assurance experience with regression testing protocol development
• Proficiency in risk management activities and test method development
• Experience with medical device development, requirements definition, and V&V
• Knowledge of ISO 13485, ISO 14971, IEC 60601-1-2, and regulatory compliance
• Medical imaging systems or fiber optics experience preferred

Compensation: $90,000 - $110,000 base plus annual bonus