Philips · 7 hours ago
Software Design Quality Assurance Engineer
Bothell, Washington, United States
Full-time
Onsite
Mid, Senior Level
$102K/yr - $164K/yr
3+ years expPhilips is a health technology company committed to improving healthcare access globally. They are seeking a Software Design Quality Assurance Engineer responsible for developing and managing software quality documentation while ensuring compliance with regulatory standards throughout the software lifecycle.
ElectronicsConsumer GoodsWellnessB2BConsumer ElectronicsLighting
No H1B
U.S. Citizen Only
Responsibilities
Leads the assessment of software designs by reviewing test and performance data to uphold quality, safety, and regulatory standards, and address any engineering deficiencies
Conducts detailed root cause analyses for software quality issues and validating key design inputs like usability, reliability, and performance
Implements software quality plans and risk management activities, utilizes post-market analytics to monitor software performance, and initiates corrective actions as needed
Develop global regulatory strategies by creating and implementing regulatory roadmaps aligned with market trends, legislation, product marketing objectives and staying current on evolving regulations to advise senior leadership on strategic decisions
Be a regulatory authority liaison, acting as the business unit contact with regulatory bodies, ensuring clear communication and fostering relationships to influence decisions and secure approvals
Lead our regulatory compliance team by providing guidance, managing talent, and driving succession planning and growth while maintaining compliance and achieving organizational goals
Ensure compliance across the product lifecycle by overseeing regulatory planning and execution for new products and changes as well as managing filings and approvals by overseeing preparation and submission of documentation for global registrations to enable timely market access
Drive regulatory excellence and continuous improvement by developing plans, assessing risks, implementing actions, and optimizing regulatory processes for efficiency while maintaining high compliance standards
Qualification
Required
Minimum of 3+ years' experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Controls
Knowledge of Risk Management (ISO 14971)
Experience in SDLC
Experience in Mobile Applications and/or SaMD
Proven experience in Software Design Verification/Validation
Experience in Root Cause analysis and Defect Management
Detailed experience in identifying, promoting, and supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Reliability (DfR), Agile, and SAFe
Ability to share knowledge, insights regarding software quality standards, and regulatory requirements
Minimum of a Bachelor's Degree in Quality, Computer Science/Engineering or similar disciplines
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Preferred
Experience in Mobile Applications and/or SaMD
ISTQB certification desired
Benefits
Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement
And much more.
Company
Philips
Philips is a technology company that operates in various fields, including healthcare, consumer electronics, lighting, and home appliances.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$4.23BKey Investors
EXOR N.V.Bill & Melinda Gates FoundationInnovative Health Initiative
2025-03-19Post Ipo Equity
2024-05-23Post Ipo Debt· $756.82M
2023-11-07Grant· $44.6M
Leadership Team
Roy Jakobs
President and CEO
Recent News
2026-02-11
Company data provided by crunchbase