Manufacturing Engineer

JOB DESCRIPTION

Manufacturing Engineer

Department: Manufacturing

Reports To: Sr. Manufacturing Manager

Location: Naples, FL

Classification: Full-Time, Exempt

Position Summary

Skeletal Dynamics is a precision contract manufacturing facility specializing in Class II orthopedic implants (ISO 13485 certified, titanium precision machining). We are looking for a Manufacturing Engineer to own investigations, drive process improvements, and lead continuous improvement initiatives across the facility. This role works alongside our existing Quality Engineer (who owns document control and QMS maintenance) and focuses on the analytical, problem-solving, and process optimization side of the operation.

This is a hands-on engineering role in a fast-paced, technology-forward environment. You will be expected to leverage AI tools (Claude, ChatGPT, etc.), data visualization platforms (Power BI), and modern analytics to accelerate your work and multiply your impact. We are a small, high-trust team — you will have real ownership from day one.

Core Responsibilities

Investigations & Root Cause Analysis

• Lead NCR (nonconformance report) investigations from identification through disposition, including containment, root cause analysis, and corrective action.
• Own the CAPA (corrective and preventive action) process — identify systemic issues, develop sustainable corrective actions, verify effectiveness, and close out with full documentation.
• Conduct structured root cause analysis using 5-Why, Ishikawa, fault tree analysis, and other methodologies appropriate to the failure mode.
• Interface with customers on quality escapes, investigations, and corrective action responses.

Process Improvement & Continuous Improvement

• Identify, prioritize, and execute process improvement projects across machining, inspection, and post-processing operations
• Apply lean manufacturing principles and continuous improvement methodologies to reduce waste, improve cycle times, and increase first-pass yield.
• Develop and maintain statistical process control (SPC) programs; monitor Cpk/Ppk and drive process capability improvements.
• Support process validation activities (IQ/OQ/PQ) for new equipment, tooling, and process changes.
• Evaluate and recommend fixture, tooling, and workholding improvements to improve quality and throughput.

Automation & Capital Improvement Projects

• Evaluate, justify, and lead implementation of automation projects including robotic machine tending, automated inspection, and lights-out manufacturing capability.
• Develop business cases and ROI analyses for capital equipment and automation investments.
• Own project management for automation deployments — vendor evaluation, installation, validation, and production handoff.
• Collaborate with equipment vendors and integrators to define requirements, review designs, and manage timelines.
• Identify opportunities to reduce manual handling, improve repeatability, and increase throughput through technology adoption.

Supplier Quality Support

• Support incoming material inspections and supplier nonconformance resolution.
• Assist with supplier qualification, audits, and performance monitoring as needed.
• Collaborate with supply chain on supplier corrective action requests (SCARs).

Data Analysis & Reporting

• Build and maintain Power BI dashboards to track quality metrics, NCR trends, CAPA status, scrap rates, and process capability.
• Use AI tools (Claude, etc.) to accelerate document drafting, data analysis, investigation summaries, and reporting workflows.
• Present data-driven improvement recommendations to leadership with clear ROI justification.

Qualifications

Required

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or related discipline.
• 2–3 years of engineering experience in a manufacturing environment, preferably medical device or aerospace.
• Working knowledge of ISO 13485, FDA 21 CFR 820, or equivalent regulated quality management systems.
• Demonstrated experience with NCR/CAPA investigation and root cause analysis methodologies.
• Proficiency with data visualization tools (Power BI preferred) and Microsoft Office Suite.
• Comfort with AI-assisted workflows — experience using LLMs (Claude, ChatGPT) and a willingness to push the boundaries of how AI tools can be applied in a manufacturing/quality context.
• Strong written and verbal communication skills; ability to write clear, audit-ready documentation.

Preferred

• Experience in CNC machining or precision manufacturing environments.
• Familiarity with GD&T, CMM inspection, and metrology fundamentals.
• Exposure to lean manufacturing, Six Sigma, or structured CI methodologies (certification not required).
• Experience with ERP/MES/QMS platforms (e.g., Business Central, 1Factory, Greenlight Guru, MachineMetrics, or similar).
• Exposure to industrial automation, robotics, or machine tending systems (collaborative robots, automated loading/unloading, vision systems).
• SPC/statistical analysis experience (Minitab, JMP, or equivalent).

What We Offer

• A high-trust, low-bureaucracy environment where your work has direct, visible impact on the business.
• Exposure to cutting-edge manufacturing technology and AI-driven workflows — this is not a traditional shop floor.
• A facility built 100% digital from day one — fully integrated ERP, QMS, MES, and machine monitoring systems.
• Ownership and autonomy from day one — we hire smart people and get out of their way.
• Competitive compensation, benefits, and growth opportunity in a rapidly evolving organization.

Skeletal Dynamics is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected characteristic.