New · posted Oct 15
Cardinal Health · Medical Devices
Sr. Principal, Product Software Design Quality Engineer
- Hazelwood, MO
- Hybrid
- Full-time
- Senior & Principal
Closes Nov 6, 2026 · 23 days left
The role
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.
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.
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.
What you need
- 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 you'll do
- 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
Pay and benefits
$106,700 – $152,400 a year
Employer providedWhat is expected of you and others at this level
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
Application window anticipated to close: 11/6/2026 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Paid parental leave
Short- and long-term disability coverage
Where you'll work
Hazelwood, MOHybridOpen in Maps (opens in a new tab)
More jobs in Hazelwood, MOEqual opportunity, accessibility and legal noticesCardinal Health's statements, word for word
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 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.
To read and review this privacy notice click here
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $106,700 | — | $152,400 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: Cardinal Health's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Cardinal Health's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems10
- Validation and qualification5
- Collaboration and leadership5
- Lab testing and methods4
- Documentation and SOPs4
- Quality systems and risk4
- GMP and compliance2
- Investigations and CAPA2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Cardinal Health on Regulatory Jobs
- 38
- Open roles
- 32
- Distinct roles
- 19
- Locations
By discipline
- Quality32 84%
- Regulatory3 8%
- Compliance & Safety3 8%
By level
- Senior & Principal23 61%
- Manager6 16%
- Associate & Specialist6 16%
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Sr. Principal, Product Software Design Quality Engineer at Cardinal Health
Applications close November 6. $107K–$152K a year, employer provided.