Principal Systems Engineer - Medical Devices (Polarion ALM)

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?

• Health Benefits
• Referral Program

Excellent growth and advancement opportunities