Philips

Senior Software Design Assurance Engineer

Philips

full-time

Posted on:

Location Type: Office

Location: Colorado Springs • California, Colorado, Minnesota • 🇺🇸 United States

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Salary

💰 $80,000 - $135,000 per year

Job Level

Senior

About the role

  • Support New Product Development and Sustaining projects within Image Guide Therapy
  • Develop and Review SW Design Verification Plans, Protocol and Reports
  • Conduct SW Design Verification per SW Design Verification Plan and Protocol
  • Develop and Review Quality plans
  • Lead and support development, design verification and hypercare of non-product software assessments and qualification efforts
  • Create and review risk management file including risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination
  • Ensure Risk Management is effective utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc.
  • Serve as SME for Software Design Assurance and collaborate on code review, unit tests, software security analysis, defect and vulnerability triage, and other best practices

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
  • hands on experience with SW Design verification and/or development.
  • Expertise in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304
  • working knowledge with IEC 60601 and other relevant medical device standards
  • Experience with software development lifecycle methodologies including Agile and SAFe
  • Experience with Defect tracking and management tools such a Jira or Clearquest
  • Proficient in Statistical software solutions such as JMP or Minitab
  • Proficient in Requirements and Traceability management tool such as JAMA, IBM DOORs etc.
Benefits
  • PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • stock purchase plan
  • education reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Software Design VerificationQuality Plans DevelopmentRisk ManagementFMEAsSoftware Risk AssessmentStatistical Software SolutionsRequirements ManagementTraceability ManagementDefect TrackingSoftware Development Lifecycle
Soft skills
LeadershipCollaborationCommunicationProblem SolvingAttention to Detail