Principal Quality Engineer - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave Reducer)

Johnson & Johnson seeks a Principal Quality Engineer to lead design assurance for the Shockwave Reducer medical device program in Minnesota. The role ensures compliance with ISO 13485 and regulatory requirements throughout product development, from design review through manufacturing transfer, while mentoring senior engineers and serving as a regulatory subject matter expert.

Responsibilities

• Lead quality assurance activities for new cardiovascular device development programs
• Develop and maintain risk management files, hazard analyses, FMEAs, and Design History Files
• Review and approve verification and validation protocols, test methods, and reports for compliance
• Partner with manufacturing and operations on design transfer, process validation, and supplier qualification
• Serve as subject matter expert during regulatory audits, inspections, and submission preparation

Requirements

• Expert knowledge of ISO 13485 and medical device regulatory requirements (FDA, Notified Body)
• Demonstrated experience leading design assurance and risk management for medical devices
• Strong proficiency in design history file management, FMEA, and verification/validation oversight
• Advanced understanding of biocompatibility, sterilization, and packaging validation standards
• Experience with design transfer, manufacturing process validation, and supplier quality management
• Ability to interpret and apply relevant medical device standards and guide design teams
• Proven mentoring and technical leadership capability with senior engineering teams