Sr Electro-Mechanical Systems Engineer II Medical Devices

Arthrex GmbH; Naples (FL); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Paid Parental Leave

Paid Time Off

Tuition Reimbursement Program

Job summary

Arthrex, Inc. seeks an Electro-Mechanical Systems Engineer Sr II to lead cross-functional product development on the Digital Innovation team in Naples, FL.

You will develop system architectures, define requirements, integrate hardware and software, and drive reliability, regulatory compliance (IEC/ISO/FDA) and design controls through the product life cycle. A Bachelor's in Engineering and 8 years of experience are required; Master's preferred. Travel 10–15% may be required.

Qualifications

• 8 years of relevant work experience required.
• Bachelor’s degree in Engineering required.
• Master’s degree preferred.
• Experience with FDA and ISO guidelines for medical devices.

Responsibilities

• Leads multifunctional new product project teams through feasibility, planning, and execution.
• Develop system architecture documentation and system-level requirements.
• Integrate hardware and software components and manage product reliability initiatives.
• Ensure compliance with Arthrex QMS and global regulatory standards.
• Collaborate with quality, regulatory, product management, and manufacturing teams.
• Coordinate external development partners and design verification activities.
• Support regulatory audits and design control documentation.

Skills

Systems engineering

Project management

Regulatory knowledge

Technical communication

Lifecycle experience

Education

Bachelor’s degree in Engineering

Master’s Degree

Job description

Arthrex, Inc. seeks an Electro-Mechanical Systems Engineer Sr II to lead cross-functional product development on the Digital Innovation team in Naples, FL.

You will develop system architectures, define requirements, integrate hardware and software, and drive reliability, regulatory compliance (IEC/ISO/FDA) and design controls through the product life cycle. A Bachelor's in Engineering and 8 years of experience are required; Master's preferred. Travel 10–15% may be required.