Project Engineer, Quality Engineering

As a Product Design Quality Engineer, you will play a critical role in ensuring the quality, safety, reliability, and regulatory compliance of innovative healthcare products throughout the product lifecycle. You will partner closely with R&D, manufacturing, regulatory, and cross-functional teams to support product development activities from concept through commercialization and post-market monitoring.

In this role, you will help drive Design Quality excellence by applying quality engineering principles, risk management methodologies, and continuous improvement practices to ensure products meet customer expectations and applicable regulatory requirements.

• Develop and execute process validation strategies utilizing statistical methodologies to support successful product transfers into manufacturing while ensuring compliance with quality and regulatory standards.
• Lead and support Design Control activities, including design input reviews, verification, validation, and design transfer processes in accordance with established quality system requirements.
• Create, review, and maintain quality engineering documentation, including quality plans, risk management files, design history file (DHF) documentation, and validation reports.
• Partner with cross-functional teams to integrate quality, reliability, and Post-Market Surveillance (PMS) insights into product development and lifecycle management activities.
• Conduct design and product quality assessments, analyze performance data, and perform root cause investigations to identify and resolve quality issues.
• Evaluate critical design attributes including usability, performance, reliability, manufacturability, safety, privacy, and security requirements.
• Facilitate risk management activities throughout the product lifecycle, ensuring risks are identified, assessed, controlled, and monitored appropriately.
• Analyze post-market product performance and customer feedback to identify improvement opportunities and support corrective and preventive actions.
• Support internal and external audits, inspections, and compliance activities while maintaining audit-ready documentation and processes.
• Lead and execute CAPA activities, including issue investigation, root cause analysis, corrective action implementation, and effectiveness verification.
• Drive continuous improvement initiatives that enhance product quality, process effectiveness, and regulatory compliance.
• Build strong relationships across engineering, manufacturing, quality, regulatory, and supplier teams while providing quality guidance and mentorship as needed.

• Bachelor's or Master's degree in Mechanical Engineering, Electrical/Electronics Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Bachelor's degree with a minimum of 2 years of experience in Quality Engineering, Design Quality, Safety Engineering, Product Development, R&D, or a related engineering discipline; or
• Master's degree with no prior professional experience required.
• Knowledge of quality engineering principles, design controls, risk management, and regulated product development environments.
• Strong analytical and problem-solving skills with the ability to evaluate data and identify trends.
• Effective communication and collaboration skills within cross-functional teams.

• Experience working in the medical device, healthcare technology, or other regulated industry environments.
• Six Sigma Green Belt certification or equivalent process improvement training.
• Familiarity with design verification and validation activities.
• Experience supporting CAPA, complaint investigations, and post-market quality processes.
• Knowledge of FDA, ISO 13485, IEC 62304, ISO 14971, and other applicable regulatory standards.

• Design Quality Management
• Design for Quality (DFQ)
• Data Analysis and Interpretation
• Root Cause Analysis (RCA)
• Corrective and Preventive Action (CAPA)
• Risk Management and Risk Assessment
• Regulatory Compliance
• Product Quality and Reliability
• Design Verification and Validation
• Privacy, Safety, and Security
• Technical Documentation
• Product…