Principal Systems Engineer, R&D Device & Combination Product Development

Added
2 hours ago
Type
Full time
Salary
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Related skills

risk management compliance systems engineering iso 13485 design controls

📋 Description

  • User and Stakeholder Needs Definition
  • System Requirements Definition
  • Risk Management Planning and reporting in accordance with ISO 14971
  • System Risk Assessment
  • Use Error Risk Assessments
  • Design Control Traceability

🎯 Requirements

  • BS in Engineering, Science, or related discipline with 14+ years of experience; OR MS with 12+
  • Demonstrated ability to resolve complex technical and compliance challenges through expert
  • Expertise in medical device and/or combination product development including strong knowledge of
  • Expertise in Systems Engineering principles, including User and Stakeholder Needs definition
  • Expertise in DHF development, maintenance, and governance
  • Experience supporting internal audits, external audits, certification body assessments, and

🎁 Benefits

  • Comprehensive package of benefits including paid time off (vacation, holidays, sick)
  • Eligible to participate in long-term incentive programs
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