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Philips · 2 months ago

Sr. Software Design Assurance Engineer

Colorado Springs, CO

Full-time

Hybrid

Senior Level, Lead/Staff

$80K/yr - $135K/yr

8+ years exp

Philips is a health technology company dedicated to providing quality healthcare for everyone. They are seeking a Senior Software Design Assurance Engineer to support New Product Development and Sustaining projects by ensuring software design quality assurance through verification plans, risk management, and collaboration with teams on best practices.

B2BConsumer ElectronicsElectronicsLightingWellness

No H1B

Responsibilities

Develop and Review SW Design Verification Plans, Protocol and Reports. Conduct SW Design Verification per SW Design Verification Plan and Protocol. Developing and Reviewing Quality plans

Leading and supporting the development, design verification and hypercare of non-product software assessments and qualification efforts

Leading the creation and review of risk management file to include the risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination

Ensuring Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc. Expertise in ISO 14971, Risk Management for medical devices and IEC 62304 Medical Device Software

Serving as SME for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, defect and vulnerability triage, creation and review of sBOMs, etc. and leading implementation of best practices for software quality processes

Qualification

Software Design VerificationRisk ManagementISO 14971IEC 62304Software Development LifecycleAgile MethodologiesStatistical SoftwareDefect Tracking ToolsCollaborationCommunication

Required

B.S./ M.S. in relevant engineering field (e.g. Biomedical, Computer Science, Software Development, Electrical etc.)

8+ years of experience in Software Quality and/or Software Development in medical device industry with hands on experience with SW Design verification and/or development

Expertise in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards

Experience with software development lifecycle mythologies including Agile and SAFe, Defect tracking and management tools such a Jira or Clearquest

Statistical software solutions such as JMP or Minitab, Requirements and Traceability management tool such as JAMA, IBM DOORs etc

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position