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Principal Systems Engineer Medical Devices (Polarion ALM)

ICONMA, LLC

  • Cincinnati, OH
  • 1 day ago
  • $35.71 Per Hour
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Skills

  • Analysis Skillsunmatched
  • Biomedical Engineeringunmatched
  • Continuous Improvementunmatched
  • Cross-Functionalunmatched
  • D Programming Languageunmatched
  • Design Verificationunmatched
  • Documentationunmatched
  • FDA (Food and Drug Administration)unmatched
  • Failure Analysisunmatched
  • Hazard Analysisunmatched
  • Health Planunmatched
  • Healthcare Qualityunmatched
  • Hospitalunmatched
  • Human Factorsunmatched
  • ISO (International Organization for Standardization)unmatched
  • Implantsunmatched
  • Information Technology Consultingunmatched
  • Instrumentationunmatched
  • Manufacturingunmatched
  • Marketingunmatched
  • Material Scienceunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Medical Productsunmatched
  • Mentoringunmatched
  • Multiplatform/Cross-Platformunmatched
  • Orthopedicsunmatched
  • Problem Solving Skillsunmatched
  • Product Developmentunmatched
  • Product Documentationunmatched
  • Product Supportunmatched
  • Program Planningunmatched
  • Project/Program Managementunmatched
  • Quality Managementunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Requirements Managementunmatched
  • Research & Development (R&D)unmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Supply Chainunmatched
  • Systems Engineeringunmatched
  • Systems Maintenanceunmatched
  • Technical Supportunmatched
  • Technical Writingunmatched
  • Technical/Engineering Designunmatched
  • Test Plan/Scheduleunmatched
  • Test Strategyunmatched
  • Traceabilityunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched
  • Validation Testingunmatched
  • Verification Plansunmatched

Description

Our Client, an IT Services and Consultant company, is looking for a Principal Systems Engineer – Medical Devices (Polarion ALM) for their Cincinnati, OH location.
 
Responsibilities:
  • Develop, write, maintain, and communicate system-level requirements for Hip and Knee R&D programs in Polarion, ensuring traceability from user needs through design inputs, verification, validation, and design outputs.
  • Serve as a requirements liaison across implants, instrumentation, and digital enablement by translating system needs, interface expectations, and workflow dependencies into clear requirements and alignment points for cross-functional teams.
  • Support design control activities, including requirements management, risk management, design reviews, verification and validation planning, change impact assessment, and design history documentation.
  • Translate surgeon, patient, hospital, commercial, and regulatory needs into actionable technical requirements that support safe, effective, manufacturable, and globally scalable orthopaedic solutions.
  • Lead or contribute to system-level hazard analysis, use-related risk assessment, failure mode evaluation, and risk control verification in partnership with quality, clinical, human factors, and regulatory teams.
  • Develop and review test strategies, protocols, acceptance criteria, and technical rationale for system, subsystem, and interface verification.
  • Facilitate technical decision-making by framing options, documenting assumptions, assessing risks, and aligning stakeholders around evidence-based recommendations.
  • Support global product development teams by ensuring requirements, architecture, and verification strategies are consistent across regions, platforms, and lifecycle phases.
  • Contribute to continuous improvement of systems engineering practices, templates, tools, requirements repositories, and cross-platform standards for Hip and Knee R&D.
  • Mentor junior engineers and cross-functional partners on systems thinking, requirements quality, traceability, and structured problem solving.
 
Requirements:
  • Polarion Expertise
  • Medical Device Design Controls,
  • Systems Engineering & Requirements Management
  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Science, or a related technical discipline; advanced degree preferred.
  • 5-10 years of experience in medical device product development, systems engineering, design engineering, R&D, or a closely related technical role.
  • Experience working within regulated medical device development processes, including design controls, requirements management, risk management, verification, validation, and technical documentation.
  • Working knowledge of medical device quality and regulatory expectations, including ISO 13485, ISO 14971, FDA Quality Management System requirements, and global product development documentation practices.
  • Demonstrated ability to translate clinical or customer needs into clear, testable, traceable system and subsystem requirements.
  • Polarion-native capability, including hands-on experience developing, structuring, managing, and maintaining requirements, traceability, reviews, baselines, and change impact assessments within Polarion.
  • Experience collaborating with multidisciplinary teams across R&D, quality, regulatory, clinical, manufacturing, supply chain, marketing, and external partners. Experience with Project management inputs to develop program plans.
  • Strong analytical, problem-solving, communication, and facilitation skills, with the ability to influence without direct authority.
  • Manufacturing locations, labs, customer engagements, or professional meetings as needed.
  • Years of Experience:   10.00 Years of Experience
 
Why Should You Apply?Excellent growth and advancement opportunities

Numbers & Facts

LocationCincinnati, OH
Salary$35.71 Per Hour

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