Sr. Principal, Product Software Design Quality Engineer

Cardinal Health•Hazelwood, MO

1d•Hybrid

About The Position

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. The position’s primary focus areas include software design control—reviewing and approving software plans, requirements, architecture, traceability, verification and validation, anomaly assessments, design transfer, release, and maintenance activities—and software risk management, ensuring 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.

Requirements

Bachelor’s degree in a 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.

Nice To Haves

Experience with embedded software, firmware, connected devices, cloud platforms, mobile applications, Software as a Medical Device, or Class II/III medical devices, preferred.
ASQ, software quality, cybersecurity, or related certification, preferred.

Responsibilities

Apply advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
Participate in the development of policies and procedures to achieve specific goals.
Recommend new practices, processes, metrics, or models.
Work on or lead complex projects of large scope that may have significant and long-term impact.
Provide solutions that 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 determine the method for completing new projects while receiving guidance on overall project objectives.
Mentor less experienced colleagues.