Mechanical Engineer  - Medical Devices, Direct Hire. 
(Duluth, GA) 

We are seeking a highly experienced Mechanical Engineer to provide hands-on design and development of next-generation battery-powered orthopedic surgical power tools.

Position Summary:
As a core member of our Engineering group, you will take ownership of designing, prototyping, and testing novel medical devices and fixtures. This is a highly hands-on role where you will bridge the gap between mechanical design, electrical prototyping, and rigorous regulatory compliance. You will work closely with electrical engineers, quality assurance, and clinical specialists to ensure our products exceed the highest standards of safety, quality, and efficacy. New role created due to growth.

Key Responsibilities:
Mechanical Design & CAD: Create detailed 3D models, complex assemblies, and production-ready drawings using SolidWorks. Utilize the principles of Design for Manufacturing (DFM) and Design for Assembly (DFA) concerning CNC machining, injection molding, and material biocompatibility.
Tolerance Analysis: Perform rigorous tolerance stack-up analyses incorporating GD&T (Geometric Dimensioning and Tolerancing) principles to ensure optimal fit, form, and function.
Prototyping: Rapidly iterate designs utilizing internal 3D printing technologies and traditional workshop tools. 
Fixture Design & Build: Design and build custom hands-on test fixtures to support verification and validation testing. Incorporate basic electrical circuit design, including working with microcontroller (i.e. Arduino) circuits for electromechanical operation.
Testing & Documentation: Author comprehensive test protocols and reports to support design verification and engineering studies.
Regulatory Compliance: Ensure all design and documentation practices strictly align with 21 CFR Part 820 (Quality System Regulation), ISO 13485, and ISO 14971 standards.

Required Qualifications & Skills:
Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
Experience: 3+ years of professional engineering experience within the medical device field.
Client has been serving patients and providers for more than 17 years. What started as a regional leader in orthopedic bracing has transformed into a nationwide Stock-and-Bill provider — designed to meet the needs of urgent care clinics and patients across the U.S. 

They partner with urgent care clinics nationwide to deliver braces directly to patients, while we manage billing, compliance, and payer requirements in the background. This eliminates administrative burden for clinics and ensures patients receive the care they need without delay. With deep experience in DMEPOS and a renewed commitment to innovation, they’ve redefined what it means to be a brace provider in modern healthcare.

Specialties: Orthopedic Bracing, Alternative Pain Management, Electrotherapy, Back, Knee, Ankle Braces, DMEPOS, Stock-and-Bill, Compliance Management, Urgent Care Partnerships, Nationwide Distribution, and Healthcare Automation Integration.

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