Sr. Principal, Product Software Design Quality Engineer
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 focuses on reviewing and approving software plans, requirements, architecture, traceability, verification and validation, anomaly assessments, design transfer, release, and maintenance activities. It also ensures 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 for cross-functional collaboration, stakeholder engagement, and key business activities. The 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 the 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).
- ASQ, software quality, cybersecurity, or related certification (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).
Responsibilities
- Apply advanced knowledge and technical capabilities to manage a wide variety of projects.
- Participate in developing 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, 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 methods for completing new projects while receiving guidance on overall project objectives.
- Mentor less experienced colleagues.
Benefits
- Medical, dental, and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before payday with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
- Bonus eligible
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
