Senior Design Engineer-Spine/Spinal Medical devices

W3Global; Dallas (TX); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

W3Global in Dallas, TX is seeking a Senior Design Engineer for Spine/Spinal Medical Devices. You will lead mechanical design, verification, validation, and transfer of products from concept through manufacturing.

Ideal candidates have 5+ years in medical device development, hands-on experience with implantables or spine-related products, and strong CAD and regulatory knowledge. This is a fully on-site role requiring collaboration with R&D, QA, Manufacturing, and Regulatory Affairs to meet

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of engineering experience within the medical device industry.
• Experience with medical device product development across design, testing, verification/validation, and manufacturing transfer.
• Proficient in SolidWorks and creating detailed drawings/ CAD models.
• Familiarity with FDA regulations, including 21 CFR Part 820 and ISO 13485.

Responsibilities

• Serve as the technical leader for medical device product development projects.
• Lead mechanical engineering activities throughout the product development lifecycle.
• Develop and refine mechanical designs for new and existing medical devices.
• Create detailed 3D CAD models and mechanical designs using SolidWorks.
• Generate detailed engineering drawings, component specifications, assemblies, and other technical documentation.
• Evaluate product concepts for performance, manufacturability, reliability, and usability.
• Support design iterations based on engineering analysis, testing, manufacturing feedback, and customer/surgeon input.

Skills

Mechanical Engineering

Medical Device Product Development

Design Verification

Design Validation

Design Transfer

3D CAD Modeling

Engineering Drawings

DFM

Regulatory Knowledge

Education

Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related field

Tools

SolidWorks

FEA / Numerical Modeling

Job description

Title: Senior Design Engineer-Spine/Spinal Medical devices

Location: Dallas, TX 75204

Work Location: In Person / On-Site

Job Type: Full-Time

Industry: Medical Devices / Healthcare Technology

Work Schedule: Monday-Friday, in-office

Experience Required: 5+ years in the medical device industry

Position Overview

We are seeking an experienced and technically strong Senior Design Engineer - Medical Device to join our team in Dallas, TX. This position will play a key role in design, development, verification, validation, improvement, and manufacturing transfer of new and existing medical device products.

The ideal candidate will have a strong foundation in mechanical engineering and medical device product development, with hands‑on experience taking products from concept and detailed design through testing, verification/validation, and manufacturing. Experience with implantable medical devices, surgical instrumentation, and/or spine-related products is highly preferred.

The Senior Design Engineer will work closely with Research & Development, Quality Assurance, Manufacturing, and Regulatory Affairs to ensure products meet technical, quality, manufacturing, and regulatory requirements.

This is a highly collaborative, hands‑on engineering position requiring strong problem‑solving skills, attention to detail, project ownership, and the ability to manage multiple development activities simultaneously.

Key Responsibilities

Product Design & Development

• Serve as the technical leader for assigned medical device product development projects.
• Lead mechanical engineering activities throughout the product development lifecycle.
• Develop and refine mechanical designs for new and existing medical devices.
• Create detailed 3D CAD models and mechanical designs using SolidWorks.
• Generate detailed engineering drawings, component specifications, assemblies, and other technical documentation.
• Evaluate product concepts for performance, manufacturability, reliability, and usability.
• Support design iterations based on engineering analysis, testing, manufacturing feedback, and customer/surgeon input.

Design Verification & Validation

• Participate in and/or lead design verification and validation activities for medical device products.
• Develop and support engineering test plans, protocols, and reports.
• Analyze test results and identify opportunities for design improvements.
• Apply engineering analysis techniques such as FEA, numerical modeling, and risk analysis to support product development decisions.
• Ensure designs meet applicable performance, reliability, safety, and regulatory requirements.

Medical Device Manufacturing & Design Transfer

• Lead and support design transfer activities from R&D into manufacturing.
• Work closely with Manufacturing Engineering and production teams to ensure designs are manufacturable and scalable.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Resolve design and production issues during manufacturing transfer and product launch.
• Develop and maintain component specifications, drawings, and other engineering documentation required for manufacturing.
• Support process and product improvements for existing medical device products.

Existing Product Improvements

• Manage and prioritize product upgrades, engineering changes, and continuous improvement initiatives.
• Evaluate existing products for opportunities to improve performance, reliability, manufacturability, and customer experience.
• Investigate product issues and develop appropriate engineering solutions.
• Execute corrective actions and engineering improvements based on customer and surgeon feedback.
• Support engineering change activities and maintain appropriate product documentation.

Regulatory & Quality

• Ensure product development activities comply with applicable FDA medical device regulations, including 21 CFR Part 820.
• Work within an ISO 13485-compliant quality system.
• Collaborate with Quality Assurance and Regulatory Affairs throughout the product development process.
• Support regulatory documentation and submissions.
• Ensure design documentation is complete, accurate, traceable, and maintained according to applicable procedures.
• Participate in risk management and design‑control activities.
• Support investigations, corrective actions, and continuous improvement initiatives as needed.

Cross-Functional Collaboration

• Partner with R&D, Quality Assurance, Manufacturing, Regulatory Affairs, and other internal teams to achieve project objectives.
• Communicate technical requirements, project status, risks, and design decisions to cross‑functional stakeholders.
• Coordinate engineering activities to meet established project schedules and milestones.
• Balance multiple projects and priorities while maintaining high standards for technical quality and documentation.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a closely related engineering discipline.
• Minimum 5 years of engineering experience within the medical device industry.
• Strong experience with medical device product development, including design, testing, verification/validation, and manufacturing.
• Demonstrated mechanical design experience using SolidWorks or comparable 3D CAD software.
• Experience creating detailed engineering drawings, component specifications, and CAD models.
• Experience with engineering analysis, such as: Finite Element Analysis (FEA), Numerical modeling Risk analysis, Engineering calculations
• Strong understanding of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
• Experience with medical device manufacturing and/or design transfer.
• Familiarity with FDA regulations, including 21 CFR Part 820.
• Familiarity with ISO 13485 requirements for medical devices.
• Strong organizational and project management skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects, priorities, and deadlines.
• Hands‑on, proactive, and results‑oriented approach to engineering.

Preferred Qualifications

• Experience designing implantable medical devices.
• Experience with surgical instrumentation.
• Experience in the spine medical device industry.
• Experience working directly with surgeons or incorporating surgeon feedback into product improvements.
• Experience supporting FDA regulatory submissions.
• Experience with medical device risk management and design controls.
• Experience taking products from concept through manufacturing transfer and commercialization.
• Experience working in a highly regulated medical device manufacturing environment.

Core Technical Skills

• Mechanical Engineering
• Medical Device Product Development
• SolidWorks
• 3D CAD Modeling
• Engineering Drawings
• Product Design
• Design Verification
• Design Validation
• Design Transfer
• FEA
• Numerical Modeling
• Risk Analysis
• DFM
• DFA
• Medical Device Manufacturing
• FDA Regulations
• 21 CFR Part 820
• ISO 13485
• Corrective Actions
• Product Improvements
• Engineering Change Management
• Regulatory Support

Key Competencies

Technical Leadership

Ability to take ownership of assigned product development projects and provide technical direction throughout the development lifecycle.

Problem Solving

Ability to investigate technical and product issues, evaluate root causes, and develop practical engineering solutions.

Project Management

Ability to organize engineering activities, establish priorities, manage deadlines, and successfully support multiple projects simultaneously.

Cross-Functional Collaboration

Ability to work effectively with R&D, Quality, Manufacturing, Regulatory Affairs, and other stakeholders.

Attention to Detail

Strong attention to engineering drawings, specifications, design documentation, regulatory requirements, and product quality.

Communication

Excellent written and verbal communication skills with the ability to communicate technical information to both engineering and non‑engineering stakeholders.

Hands-On Approach

Strong willingness to work directly with products, prototypes, testing, manufacturing teams, and engineering documentation.

Work Environment

This is a fully on-site position based in Dallas, Texas.

The Successful Candidate Must

• Currently live in the Dallas, TX area or be willing to relocate.
• Be available to work in the office five days per week.
• Be comfortable working in a collaborative, hands‑on medical device engineering environment.
• Work closely with engineering, manufacturing, quality, and regulatory teams.

This position is not remote or hybrid.

Benefits

The company offers a benefits package that includes:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance