Senior Software Engineer

The Senior Software Engineer role at Evolution Spine focuses on end-to-end product engineering for a medical device portfolio, with responsibility spanning design, development, verification, and validation while meeting applicable regulatory requirements. The position emphasizes mechanical engineering execution and cross-functional project coordination for both new and existing products.

Role Summary

Serve as a senior design engineer supporting a medical device product line. Own mechanical design and development activities across the lifecycle, including documentation, verification and validation, corrective improvements, and regulatory-facing support. Ensure project outcomes align with timelines and compliance expectations for medical devices.

Key Responsibilities

• Lead assigned product development projects from concept through execution.
• Coordinate cross-functional work with R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to meet goals and timelines.
• Perform detailed mechanical design work using SolidWorks and CAD models.
• Create detailed product drawings and component specifications.
• Manage design transfer activities from R&D to manufacturing.
• Handle and prioritize design upgrades and improvements for existing products.
• Execute corrective actions and improvement proposals informed by surgeon feedback.
• Ensure compliance with FDA regulations (e.g., 21 CFR Part 820) and ISO 13485 for medical devices.
• Support regulatory submissions as needed for the product portfolio.

Required Qualifications

• Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum 5 years of engineering experience in the medical device industry.
• Strong background in medical device product development, including 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.
• Ability to prioritize tasks and manage multiple projects effectively.
• Hands-on, driven work ethic.

Technologies and Tools

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

Benefits

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

Compensation and Work Location

• Pay: $75,000.00 - $90,000.00 per year
• Location: Dallas, TX (onsite, in person)