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Sr. Principal Engineer - Hip & Knee R&D

Belcan Services Group Ltd Partnership

Cincinnati, OHContract$50–60/hrSeen todaySeen in employer's feed today

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At a glance

Compensation
$50–60/hr
Location
Cincinnati, OH
Schedule
Contract
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs, applying systems engineering methods to orthopedic implants, instruments, and enabling technologies. The role translates clinical, customer, regulatory, quality, and business needs into system requirements, architecture decisions, verification strategies, and cross-functional alignment. It supports defined workstreams independently while partnering with technical leaders and product development stakeholders.

Skills & qualifications

RequiredNice to have

Skills

Systems EngineeringMedical Device DevelopmentDesign ControlsRequirements ManagementRisk ManagementVerification and ValidationTechnical DocumentationISO 13485ISO 14971FDA Quality Management SystemPolarionTraceabilityChange Impact Assessment

Qualifications

Bachelor's in Mechanical, Biomedical, Systems Engineering, Materials Science or RelatedAdvanced Degree5+ Years Experience

Full job description

Job Description Job Title: Sr. Principal Engineer - Hip & Knee R&DPay Rate: $50-60/hrDuration: 24-month contract Location: Cincinnati, OHZip Code: 45242Start Date: Right Away Keywords: #SystemsEngineerJobsSummary: The Systems Engineering Principal Engineer will support global Hip and Knee R&D programs by applying systems engineering methods to complex orthopedic 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 orthopedic 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 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 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,

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