Job description

Job Summary The Senior Software Quality Engineer on the Neurovascular Pre-Market Design Quality team will partner with cross-functional development teams to ensure software and system-level design activities are planned, executed, and documented in compliance with applicable quality and regulatory requirements. This role supports new product development by providing quality oversight and technical guidance throughout the design control lifecycle, with a focus on neurovascular device sizing software as a medical device system. The ideal candidate combines strong systems engineering and software development knowledge with experience in design controls, risk management, verification and validation, and regulatory expectations for medical device development. Key Responsibilities • Provide design quality support for software and software-as a medical device development programs from concept through transfer to manufacturing. • Ensure compliance with applicable design control, software lifecycle, and risk management requirements. • Review and contribute to system requirements, software requirements, architecture, and design documentation. • Support development of verification and validation strategies for software, system, and integration testing. • Partner with engineering, product development, regulatory, clinical, and quality teams to resolve design quality issues. • Evaluate software development deliverables for completeness, traceability, and regulatory readiness. • Support risk management activities, including hazard analysis, software-related risk evaluation, and mitigation verification. • Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance. • Assist in root cause analysis and corrective action activities related to design or software quality issues. • Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements. • Contribute to continuous improvement initiatives for design quality processes, tools, and templates. Required Qualifications • Bachelor's degree in Software Engineering, Computer Engineering, Electrical Engineering, Systems Engineering, or a related technical field and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience. • Demonstrated experience with design controls, software development lifecycle activities, and verification/validation. • Strong understanding of risk management principles, design failure analysis concepts, and traceability across requirements, design, and testing. • Experience supporting cross-functional product development teams. • Strong written and verbal communication skills with the ability to influence and collaborate effectively. • Ability to manage multiple priorities in a fast-paced environment. Preferred Qualifications • 5 to 8 years of experience in software engineering, systems engineering, design assurance, reliability, or quality engineering in a regulated industry. • Experience in the medical device industry or another highly regulated environment. • Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards. • Familiarity with agile development environments and how quality practices integrate into iterative development. • Experience with AI used in process development and embedded in products. • Experience with software architecture reviews, cybersecurity considerations, or usability/human factors support. • Advanced degree in engineering or a related discipline. Core Competencies • Technical depth in software and systems engineering • Quality mindset and attention to detail • Strong analytical and problem-solving skills • Cross-functional collaboration • Sound judgment and decision-making • Effective communication and documentation skills • Ability to coach and influence without direct authority Location This position is based in Irvine, CA, offering a vibrant environment with a blend of natural beauty, cultural attractions, and a thriving tech industry. Working on-site full-time, you'll be part of a dynamic team committed to delivering high-quality medical device solutions.

Requirements

Must-haves

Provide design quality support for software and software-as a medical device development programs from concept through transfer to manufacturing.
Ensure compliance with applicable design control, software lifecycle, and risk management requirements.
Review and contribute to system requirements, software requirements, architecture, and design documentation.
Support development of verification and validation strategies for software, system, and integration testing.
Partner with engineering, product development, regulatory, clinical, and quality teams to resolve design quality issues.
Evaluate software development deliverables for completeness, traceability, and regulatory readiness.
Support risk management activities, including hazard analysis, software-related risk evaluation, and mitigation verification.
Participate in design reviews and provide constructive feedback to improve product quality, safety, and compliance.
Assist in root cause analysis and corrective action activities related to design or software quality issues.
Mentor less experienced engineers on design quality practices, documentation expectations, and compliance requirements.
Contribute to continuous improvement initiatives for design quality processes, tools, and templates.
Demonstrated experience with design controls, software development lifecycle activities, and verification/validation.

Nice-to-haves

Experience in the medical device industry or another highly regulated environment.
Knowledge of IEC 62304, ISO 14971, ISO 13485, FDA design control expectations, and related standards.
Familiarity with agile development environments and how quality practices integrate into iterative development.
Experience with AI used in process development and embedded in products.
Experience with software architecture reviews, cybersecurity considerations, or usability/human factors support.
Advanced degree in engineering or a related discipline.
Core Competencies
Technical depth in software and systems engineering
Quality mindset and attention to detail
Strong analytical and problem-solving skills
Cross-functional collaboration
Sound judgment and decision-making

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

agileai

Platform: jobdiva
Effort: medium