Philips Sr Software Design Assurance Engineer 

United States, Colorado, Colorado Springs 

448824241

Your role:

• 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.

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 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 position.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Learn more about

.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.