Manufacturing Engineer

• Location – Onsite in Brooksville FL
  

• Direct Hire
  

• Salary: $85,000 – $115,000 Depending on experience
  

• Must be able to work without the need for sponsorship

Position Overview
We are seeking a Manufacturing Engineer to support production within a regulated medical device manufacturing environment. This position will serve as a key technical resource between Engineering, Manufacturing, and Quality, with responsibility for improving manufacturing processes, maintaining controlled documentation, supporting quality initiatives, and resolving production-related issues.
The ideal candidate will have strong hands-on manufacturing engineering experience and a solid understanding of ISO 13485, process validation, quality systems, and continuous improvement.
Key Responsibilities
Manufacturing & Process Engineering

• Develop, improve, and maintain manufacturing processes to support product quality, consistency, and production efficiency.
  

• Create and maintain manufacturing documentation, including:
  

  • Work instructions
    

  • Manufacturing routers
    

  • Standard operating procedures (SOPs)
    

  • Process flow documentation
    

  • PFMEAs
    

  
  

• Support process validation activities, including IQ, OQ, and PQ.
  

• Evaluate existing production processes and recommend improvements to increase capability, reliability, and throughput.
  

• Identify manufacturing bottlenecks, production risks, and opportunities for waste reduction.
  

• Provide day-to-day engineering support to manufacturing operations.

Tooling & Production Support

• Utilize SolidWorks or similar CAD software when developing or modifying designs.
  

• Troubleshoot equipment, and manufacturing process issues.
  

• Work closely with production personnel to implement sustainable technical solutions.

Quality & Regulatory Support

• Partner with Quality to ensure manufacturing processes meet applicable quality and regulatory requirements.
  

• Support First Article Inspection (FAI) activities and associated documentation.
  

• Assist with production approval and manufacturing qualification documentation.
  

• Develop and improve incoming inspection methods for raw materials and components.
  

• Investigate nonconforming materials and manufacturing defects.
  

• Participate in root cause investigations and Corrective and Preventive Action (CAPA) activities.
  

• Develop appropriate containment, rework, and corrective action strategies.
  

• Utilize Statistical Process Control (SPC) and other statistical methods to evaluate manufacturing performance and process capability.

Continuous Improvement

• Work with Engineering, Quality, Operations, and other cross-functional teams to identify and implement process improvements.
  

• Reduce scrap, rework, waste, and manufacturing inefficiencies.
  

• Improve manufacturing consistency, process capability, and overall product quality.
  

• Support implementation of new or revised manufacturing processes and equipment.
  

• Assist with training production personnel on new processes, procedures, equipment, and manufacturing changes.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related technical discipline.
  

• Manufacturing engineering experience within a production environment.
  

• Experience developing and maintaining manufacturing processes and technical documentation.
  

• Understanding of manufacturing quality systems and controlled documentation.
  

• Experience supporting process troubleshooting, root cause analysis, and corrective actions.
  

• Strong analytical and problem-solving skills.
  

• Ability to work effectively with Manufacturing, Quality, Engineering, and Operations teams.

Preferred Qualifications

• Experience within a medical device or other highly regulated manufacturing environment.
  

• Working knowledge of ISO 13485 and applicable FDA quality requirements.
  

• Experience with IQ/OQ/PQ process validation.
  

• Experience with PFMEA, CAPA, FAI, SPC, and process capability analysis.
  

• SolidWorks or comparable CAD experience.
  

• Familiarity with statistical analysis and risk-management tools.
  

• Experience using Minitab or similar statistical software.

Regulatory & Quality Expectations
This position is responsible for ensuring assigned manufacturing processes are properly developed, documented, controlled, and maintained in accordance with established quality procedures and applicable regulatory requirements.
The Manufacturing Engineer will play an important role in maintaining product quality, manufacturing consistency, traceability, regulatory compliance, and overall process reliability.
Work Environment
This position operates within a regulated manufacturing environment and requires regular collaboration with production, engineering, quality, and operations personnel.

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