Principal Systems Engineer, Orthopedics R&D

TechDigital Group; Cincinnati (OH); On-site; USD 110,000 - 170,000; Full time

Job summary

TechDigital Group is seeking a Systems Engineering Principal Engineer to lead system-level requirements for Hip and Knee R&D programs. The role emphasizes translating clinical and regulatory needs into clear specifications and ensuring rigorous design control across global teams.

The candidate will drive risk assessment, verification planning, and cross-functional alignment while mentoring junior engineers and collaborating with quality, regulatory, clinical, manufacturing, and commercial

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Science, or a related technical discipline; advanced degree preferred.

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.

Skills

Polarion Expertise

Medical Device Design Controls

Systems Engineering

Education

Bachelors in Mechanical/Biomedical/Systems Engineering

Advanced degree preferred

Tools

Polarion

Job description

TechDigital Group is seeking a Systems Engineering Principal Engineer to lead system-level requirements for Hip and Knee R&D programs. The role emphasizes translating clinical and regulatory needs into clear specifications and ensuring rigorous design control across global teams.

The candidate will drive risk assessment, verification planning, and cross-functional alignment while mentoring junior engineers and collaborating with quality, regulatory, clinical, manufacturing, and commercial