Associate Engineering Project Manager

CTL Amedica; Carrollton (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

CTL Amedica, a leader in spinal implants and surgical systems, seeks an Associate Engineering Project Manager to support the R&D team in Carrollton, TX. You will coordinate engineering and regulatory activities for product development, launches and lifecycle management.

The role requires strong organization, communication and documentation skills, with the ability to manage multiple projects and work with cross‑functional teams across engineering, quality, regulatory, manufacturing, marketing

Qualifications

• Bachelor's degree in engineering or related technical field.
• Strong organizational and project coordination skills.
• Excellent written and verbal communication skills.
• Ability to work with technical documentation and templates.
• Strong analytical and problem‑solving skills.
• Ability to manage multiple priorities in a fast‑paced environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Self‑motivated, dependable and collaborative.

Responsibilities

• Coordinate project management activities across the product lifecycle.
• Develop product lists, documentation and launch materials.
• Assist in development of training materials and technical docs.
• Coordinate communication between engineering, quality, regulatory, manufacturing, marketing and sales.
• Support customer service and sales with product inquiries and technical support.
• Assist with sales team training and technical product education.
• Track engineering and regulatory deliverables for design controls and development.
• Assist with FDA 510(k) submissions and CE Technical Files.
• Maintain Design History Files, specs and engineering records.
• Interact with surgeons and external partners for design improvements.

Skills

Organizational skills

Project coordination

Communication

Documentation

Analytical thinking

Multi-tasking

MS Office

Education

Bachelor's degree in engineering

Tools

Adobe Photoshop

Job description

CTL Amedica is an ISO 13485 certified and FDA registered medical device company headquartered in Carrollton, Texas. CTL designs, manufactures, and distributes spinal implants and surgical systems used by spine surgeons worldwide.

CTL Amedica is seeking an Associate Engineering Project Manager to support the Research & Development team. This role will coordinate engineering and regulatory activities related to product development, product launches, and lifecycle management of orthopedic implant systems.

The ideal candidate is organized, detail-oriented, technically curious, and able to manage multiple cross-functional activities simultaneously.

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Key Responsibilities

• Support project management activities across the product lifecycle including design, development, regulatory submission, product launch, and post-market improvements.
• Develop and maintain product set lists, product documentation, and launch materials.
• Assist in development of product training materials and technical documentation (e.g., surgical technique guides, product overviews, training content).
• Coordinate communication between engineering, quality, regulatory, manufacturing, marketing, and sales teams.
• Support customer service and sales teams by addressing product-related inquiries, assisting with set maintenance and compatibility questions, and providing technical support for product usage in the field.
• Support sales team training and technical product education.
• Coordinate and track engineering and regulatory deliverables related to design controls and product development documentation.
• Assist in preparation and compilation of FDA 510(k) submissions and CE Technical Files.
• Maintain and organize product documentation including Design History Files (DHF), product specifications, and engineering records.
• Interact with surgeons, consultants, and external partners to support product design improvements and feasibility evaluations.
• Assist with product lifecycle management activities, including updates, improvements, and post-market support.

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Required Qualifications

• Bachelor's degree in engineering or related technical field.
• Strong organizational and project coordination skills.
• Excellent written and verbal communication skills.
• Ability to work with technical documentation, reports, and structured forms/templates.
• Strong analytical and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Self-motivated, dependable, and able to work both independently and collaboratively.

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Preferred Qualifications

• 0-3 years of experience in the medical device or regulated industry.
• Familiarity with FDA design controls, 510(k) submissions, or ISO 13485.
• Experience supporting engineering or product development projects.
• Experience with technical documentation, regulatory files, or product launch activities.
• Familiarity with graphic or document design tools (Adobe, Photoshop, etc.).

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Education

Bachelor's Degree (Engineering or related field)