Senior Principal Medical Device Software Quality Engineer

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

Benefits offered by this job

Medical coverage

Paid time off

HSA 401k

Job summary

Cardinal Health in the United States is seeking a Product Software Design Quality Engineer to provide independent quality oversight across the software life cycle for medical device software.

You will ensure software design controls, risk management, verification/validation, cybersecurity, change control, and post-market support while collaborating with cross-functional teams in a hybrid on-site model.

Qualifications

• Bachelor’s degree in a related field or equivalent work experience; 8–12 years in software quality, design quality, validation or related regulated roles.
• Experience with medical device software and application of design controls and regulatory standards such as IEC 62304, ISO 14971 and FDA guidance.
• Strong writing, problem solving, and cross‑functional collaboration skills; familiarity with cybersecurity expectations is a plus.

Responsibilities

• Review and approve software life cycle deliverables including plans, requirements and design docs.
• Evaluate defects, anomalies and test results for safety, quality and regulatory impact.
• Escalate high-risk issues as appropriate and mentor less-experienced teammates.
• Ensure compliance with design controls, risk management, verification and validation activities.

Skills

Software quality

Design quality

Software validation

Regulated industry

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in related field

Tools

IEC 62304

ISO 14971

21 CFR Part 820

Job description

Cardinal Health in the United States is seeking a Product Software Design Quality Engineer to provide independent quality oversight across the software life cycle for medical device software.

You will ensure software design controls, risk management, verification/validation, cybersecurity, change control, and post-market support while collaborating with cross-functional teams in a hybrid on-site model.