Associate Engineering Project Manager

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.

• 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.

• 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.

• 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.).

Bachelor’s Degree (Engineering or related field)

Full-Time

$60,000-$70,000 (Based on qualifications and experience)