Philips-posted 4 months ago
$80,000 - $135,000/Yr
Full-time • Senior
Fort Carson, CO
5,001-10,000 employees

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 includes developing and reviewing SW Design Verification Plans, Protocol and Reports, conducting SW Design Verification per SW Design Verification Plan and Protocol, and developing and reviewing Quality plans. You will lead and support the development, design verification and hypercare of non-product software assessments and qualification efforts. Additionally, you will lead the creation and review of risk management files, ensuring effective Risk Management utilizing feedback from various sources. You will serve as a Subject Matter Expert (SME) for Software Design Assurance and collaborate with teams on code review, unit tests, software security analysis, and implementation of best practices for software quality processes.

  • 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 the development, design verification and hypercare of non-product software assessments and qualification efforts.
  • Lead the creation and review of risk management file including risk management plan, product hazard analysis, FMEAs, Software Risk Assessment, Risk Management Matrix, and Benefit Risk Determination.
  • Ensure effective Risk Management utilizing feedback from validation, field service, post market surveillance, manufacturing indicators, CAPAs, HHAs, etc.
  • Serve 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.
  • Lead implementation of best practices for software quality processes.
  • 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.
  • Working knowledge with IEC 60601 and other relevant medical device standards.
  • Experience with software development lifecycle methodologies including Agile and SAFe.
  • Familiarity with defect tracking and management tools such as Jira or Clearquest.
  • Experience with statistical software solutions such as JMP or Minitab.
  • Knowledge of Requirements and Traceability management tools such as JAMA, IBM DOORs.
  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement
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