Manufacturing Engineer
Skeletal Dynamicsa day ago
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OnsiteFull-timeMid
Summary
Skeletal Dynamics is seeking a Manufacturing Engineer to join their team in Naples, FL. The role involves owning investigations, driving process improvements, and leading continuous improvement initiatives in a precision contract manufacturing facility specializing in Class II orthopedic implants.
About the Role
As a Manufacturing Engineer, you will be responsible for leading NCR investigations, owning the CAPA process, and conducting root cause analysis. You will identify and execute process improvement projects, apply lean manufacturing principles, and support automation projects. Additionally, you will collaborate with suppliers on quality issues and build Power BI dashboards to track quality metrics.
About You
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 and experience using LLMs (Claude, ChatGPT).
- Strong written and verbal communication skills.
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.
- Experience with ERP/MES/QMS platforms.
- Exposure to industrial automation, robotics, or machine tending systems.
- SPC/statistical analysis experience.
Benefits
- A high-trust, low-bureaucracy environment with direct impact on the business.
- Exposure to cutting-edge manufacturing technology and AI-driven workflows.
- A fully integrated digital facility with ERP, QMS, MES, and machine monitoring systems.
- Ownership and autonomy from day one.
- Competitive compensation, benefits, and growth opportunity.
Skeletal Dynamics
Skeletal Dynamics is proud to be the only medical device company exclusively focused on the upper extremity. We provide innovation, based on science, backed by world class education and trusted service in an effort to advance surgical treatment and patient outcomes.
Bonita Springs, FL