Systems Engineering Principal Engineer

TechDigital Group; Cincinnati (OH); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

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

Formación

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

Responsabilidades

• 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.

Conocimientos

Polarion Expertise

Medical Device Design Controls

Systems Engineering

Educación

Bachelors in Mechanical/Biomedical/Systems Engineering

Advanced degree preferred

Herramientas

Polarion

Descripción del empleo

JD

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.

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.

Top Skills

• Polarion Expertise
• Medical Device Design Controls,
• Systems Engineering & Requirements Management

Additional Details

• 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.
• Ability to work across global teams and time zones, with occasional travel to R&D sites, manufacturing locations, labs, customer engagements, or professional meetings as needed.