Sr. Principal, Product Software Design Quality Engineer

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

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability covera

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

The Product Software Design Quality Engineer provides independent quality oversight throughout the life cycle of medical device software at Cardinal Health. 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 emphasizes Software Design Control and Software Risk Management, with on-site collaboration a requirement for

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, 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.

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

Job description

What Quality Engineering contributes to Cardinal Health

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.

Job Summary

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.

Primary focus areas:

• 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.

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

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, 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.

What is expected of you and others at this level

• 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

Anticipated salary range

$106,700 - $152,400

Bonus eligible

Yes

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

#LI-MP1

#LI-hybrid

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.