Senior Principal Software Quality Engineer (Medical Devices)

HITEC; Hazelwood (MO); Hybrid; USD 107,000 - 152,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Wellness programs

Job summary

Cardinal Health seeks a Product Software Design Quality Engineer to provide independent quality oversight across the lifecycle of medical device software, ensuring design controls, risk management, verification/validation, cybersecurity, change control, and post-market support.

The role collaborates with cross-functional teams to maintain safe, compliant products, with a hybrid work model and required on-site collaboration for key activities.

Qualifications

• 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, 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

Responsibilities

• 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

Skills

Software quality

Design quality

Cybersecurity

Education

Bachelor’s degree in related field

ASQ certification

Job description

Cardinal Health seeks a Product Software Design Quality Engineer to provide independent quality oversight across the lifecycle of medical device software, ensuring design controls, risk management, verification/validation, cybersecurity, change control, and post-market support.

The role collaborates with cross-functional teams to maintain safe, compliant products, with a hybrid work model and required on-site collaboration for key activities.