Senior Software Engineer

Evolution Spine offers an onsite engineering role in Dallas, TX focused on medical device product development, with a compensation range of $75,000 to $90,000 per year. You will join a cross-functional environment where engineering work directly supports product quality and regulatory-ready outcomes.

What you’ll work on

As a Sr. Design Engineer, you will lead assigned product development projects for a medical device portfolio. The work spans design, development, verification, and validation for both new and existing products, with an emphasis on meeting applicable regulatory requirements for medical devices. You will also support regulatory submissions as needed.

Responsibilities

• Lead assigned product development projects from start through completion.
• Partner across R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to meet project goals and timelines.
• Execute detailed mechanical designs using SolidWorks and CAD models.
• Create detailed product drawings and component specifications.
• Manage design transfer activities from R&D to manufacturing.
• Manage and prioritize design upgrades and improvements for existing products.
• Execute corrective actions and improvement proposals based on surgeon feedback.
• Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) and ISO 13485 for medical devices.
• Support regulatory submissions.

Requirements

• B.S. degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Minimum 5 years of engineering experience in the medical device industry.
• Deep background in medical device product development across design, testing, and manufacturing processes.
• Experience with analytical processes such as FEA, numerical modeling, and Risk Analysis.
• Experience with implantable medical devices or surgical instrumentation.
• Familiarity with design for manufacturability (DFM) and design for assembly (DFA).
• Excellent organizational and communication skills, with the ability to prioritize and manage multiple projects effectively.
• Hands-on, driven work ethic.

Tools and technologies

• SolidWorks
• CAD
• FEA
• Numerical modeling
• Risk Analysis

Benefits

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Work location: In person