Systems Engineering Principal Engineer

Job Title:Systems Engineering Principal Engineer

Location:Onsite Cincinnati, OH

Tax Term (W2, C2C):W2

Job Type (Permanent/Contract):Contract

Duration:Long Term

Description:

The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs by applying systems engineering methods to complex orthopaedic implant, instrument, and enabling technology development. This mid-level role will help translate clinical, customer, regulatory, quality, and business needs into clear system requirements, architecture decisions, verification strategies, and cross-functional technical alignment. The role is intended for an engineer who can operate independently on defined workstreams while partnering closely with senior technical leaders, product development teams, quality, regulatory, clinical, manufacturing, and commercial stakeholders.

Role and 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.

Required Skills:

• Polarion Expertise.
• Medical Device Design Controls.
• Systems Engineering & Requirements Management.
• Requirements Traceability.
• Verification & Validation (V&V).
• Risk Management.
• Hazard Analysis.
• Failure Mode Evaluation (FMEA).
• Design History File (DHF).
• ISO 13485.
• ISO 14971.
• FDA Quality Management System (QMS).
• Technical Documentation.
• Cross-functional Collaboration.

Qualifications:

• 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 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.
• Hands-on experience with Polarion, including requirements authoring, traceability, reviews, baselines, and change impact assessments.
• Experience collaborating with multidisciplinary teams across R&D, Quality, Regulatory, Clinical, Manufacturing, Supply Chain, Marketing, and external partners.
• Strong analytical, communication, problem-solving, and stakeholder management skills.
• Ability to work across global teams with occasional travel.
• 10+ years of relevant experience.