Sustainability Engineer — Spinal Implants

CTL Medical Corporation d/b/a CTL Amedica is an ISO 13485 certified, and FDA registered Medical Device Company headquartered in Carrollton, Texas. CTL designs, manufactures, and distributes medical device products and systems for spinal surgeons; specifically implants and devices.

The Sustainability Engineer is responsible for supporting and improving released spinal implant and instrumentation systems throughout their product lifecycle. This role focuses on technical problem-solving, product performance, manufacturing support, and engineering change management to ensure continued safety, regulatory compliance, and manufacturability.

This position works cross-functionally with Engineering, Manufacturing, Quality, and Regulatory Affairs to investigate product issues, implement design and process improvements, and support ongoing production of complex orthopedic implant systems.

This is a hands-on engineering role requiring strong mechanical aptitude, root cause analysis capability, and understanding of manufacturing processes for precision medical devices.

DUTIES AND RESPONSIBILITIES

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Nothing in this job description restricts management’s right to assign / reassign duties \& responsibilities to this job at any time.

Product \& Technical Support

• Lead technical investigations of nonconforming product and field complaints, performing root cause analysis and defining corrective actions.
• Conduct failure analysis of implants and surgical instruments, including dimensional review, tolerance evaluation, material assessment, and functional testing.
• Support risk assessments and updates to product risk files (ISO 14971).
• Evaluate design and process changes for impact to product performance and regulatory submissions.

Engineering Change Management

• Assist with engineering change requests for released products.
• Update drawings, tolerances, specifications, and bills of materials as required.
• Support cost reduction, manufacturability improvements, and supplier changes.
• Assess whether changes require Letter-to-File, Special 510(k), or Traditional 510(k) support (in coordination with RA).

Manufacturing \& Operations Support

• Provide technical guidance for QRB and rework decisions.
• Support in-house and supplier manufacturing issues related to machining, finishing, sterilization, and assembly.
• Review and improve inspection criteria and acceptance standards.
• Assist with fixture, tooling, and inspection method development.

Validation \& Continuous Improvement

• Support verification and validation activities related to design or process changes.
• Participate in equipment and process validations.
• Analyze trending data to identify recurring technical issues.
• Drive continuous improvement initiatives focused on product reliability and yield.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
• 2\+ years of experience in medical device product engineering, sustaining engineering, or manufacturing engineering (orthopedic/spine preferred).
• Strong understanding of engineering drawings, tolerance stack analysis, and CAD systems.
• Experience with precision machining, implant manufacturing, and/or surgical instruments preferred.
• Experience performing root cause investigations and technical failure analysis.
• Familiarity with FDA 21 CFR Part 820 (QSR) and ISO 13485 requirements.
• Working knowledge of ISO 14971 risk management principles.
• Experience with inspection tools (calipers, micrometers, CMM) and measurement system analysis (MSA).
• Strong analytical, problem-solving, and cross-functional communication skills.

NON-ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS

(not necessary but preferred)

• Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired.
• Minimum of Bachelor’s Degree in Technical Field (Engineering or Sciences) is desire
• Microsoft Office Suite.
• Previous Presentation creation and dissemination to Executive Leadership

​ONLY CANDIDATES THAT LIVE IN THE DALLAS AREA WILL BE CONSIDERED​

CTL Amedica offers a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth. If you are a creative thinker with a passion for product development and the desire to make a difference in the healthcare industry, we encourage you to apply.​

Join CTL Amedica in our mission to advance spinal healthcare through innovation and excellence.

CTL Amedica is an equal opportunity employer, and we welcome candidates from all backgrounds to apply.