Senior Systems Engineer, Medical Device Digital Innovation

Arthrex GmbH; Naples, Northern (FL, KY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Company-provided life insurance

401(k) Retirement Plan

Tuition reimbursement

Free onsite clinics

Job summary

Arthrex is seeking a Sr II Systems Engineer to lead cross-functional product development from feasibility through launch. You will define system-level requirements, architect hardware and software integrations, and drive reliability and regulatory compliance for medical devices.

Collaborate with quality, regulatory, product management, manufacturing, and external partners to deliver innovative, compliant solutions that support Arthrex's strategic objectives. Travel 10–15% may be required.

Qualifications

• FDA/ISO guidelines knowledge for medical devices.
• Experience leading cross-functional product development efforts.
• Strong project management and systems thinking.
• Ability to communicate technical concepts clearly.

Responsibilities

• Lead multifunctional new product projects through feasibility to launch.
• Define system-level requirements and ensure QMS/regulatory compliance.
• Decompose requirements into discipline-specific specs and integrate subsystems.
• Manage external development partners and lifecycle changes.
• Develop reliability plans and perform system performance assessments.

Skills

Systems Eng

Project Mgmt

Cross-functional lead

Regulatory knowledge

Technical comms

Lifecycle mgmt

DOE

Education

Bachelor's in Engineering

Master's degree preferred

Job description

Arthrex is seeking a Sr II Systems Engineer to lead cross-functional product development from feasibility through launch. You will define system-level requirements, architect hardware and software integrations, and drive reliability and regulatory compliance for medical devices.

Collaborate with quality, regulatory, product management, manufacturing, and external partners to deliver innovative, compliant solutions that support Arthrex's strategic objectives. Travel 10–15% may be required.