Job 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:
Requirements:
Why Should You Apply?Excellent growth and advancement opportunities
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
| Location | Cincinnati, OH |
| Industry | Management Consulting Services |
| Salary | $35.71 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
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Skills
- Analysis Skillsunmatched
- 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
- 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
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
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