Sr. Software Design Assurance Engineer

Koninklijke Philips N.V

7d•$80,000 - $136,000•Hybrid

About The Position

Sr. Software Design Assurance Engineer In this role you Will support New Product Development and Sustaining projects within Image Guide Therapy with respect to software, firmware, and hardware from a Software Design Quality Assurance perspective. Your role: Develop and Review SW Design Verification Plans, Protocol and s. 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. You're the right fit if: 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 ing 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 amodation for this Office/Remote position.

Requirements

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 ing 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.

Responsibilities

Develop and Review SW Design Verification Plans, Protocol and s
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
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