Sr. Principal, Product Software Design Quality Engineer

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.

The Product Software Design Quality Engineer provides independent quality oversight throughout the life cycle of medical device software. The role ensures effective software design controls, risk management, verification and validation, cybersecurity, change control, and post-market support to maintain safe, effective, and compliant products.

• Software Design Control:
  Review and approve software plans, requirements, architecture, traceability, verification and validation, anomaly assessments, design transfer, release, and maintenance activities.
• Software
  
  Risk Management:
  
  Ensure software and cybersecurity risks are identified, evaluated, controlled, verified, and monitored throughout the product life cycle.

This position follows a hybrid work model and requires regular on-site presence to support cross-functional collaboration, stakeholder engagement, and key business activities. The specific frequency of on-site attendance may vary based on business needs, project requirements, and team objectives.

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participates in the development of policies and procedures to achieve specific goals
• Recommends new practices, processes, metrics, or models
• Works on or may lead complex projects of large scope
• Projects may have significant and long-term impact
• Provides solutions which may set precedent
• Review and approve software life cycle deliverables, including plans, requirements, design documentation, traceability, verification and validation, configuration records, anomaly assessments, and release documentation.
• Evaluate defects, anomalies, deviations, test failures, and unresolved issues for safety, quality, cybersecurity, regulatory, and release impact. Escalate high-risk issues as appropriate.
• Independently determines method for completion of new projects
• Receives guidance on overall project objectives
• Acts as a mentor to less experienced colleagues

• Bachelor’s degree in related field, or equivalent work experience, preferred
• 8-12 years of experience in software quality, design quality, software validation, software development, systems engineering, or a related regulated-industry role, preferred.
• Experience with medical device software and application of design controls, IEC 62304 software life cycle processes, ISO 14971 risk management, verification and validation, configuration management, and change control, preferred
• Working knowledge of 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1, IEC 60601, applicable FDA software guidance, and medical device cybersecurity expectations, preferred
• Experience with requirements and traceability, software testing, anomaly management, root cause analysis, CAPA, and audit support, preferred
• Strong technical writing, problem-solving, organizational, communication, and cross-functional collaboration skills, preferred
• Experience with embedded software, firmware, connected devices, cloud platforms, mobile applications, Software as a Medical Device, or Class II/III medical devices, preferred, preferred
• ASQ, software quality, cybersecurity, or related certification, preferred.

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Participates in the development of policies and procedures to achieve specific goals.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope.
• Projects may have significant and long-term impact.
• Provides solutions which may set precedent.
• Review and approve software life cycle deliverables, including plans, requirements, design documentation, traceability, verification and validation, configuration records, anomaly assessments, and release documentation.
• Evaluate defects, anomalies, deviations, test failures, and unresolved…