Director Manufacturing Medical Device Jobs (NOW HIRING)

About the Role:
The Manufacturing Engineer will support precision manufacturing, process engineering, and continuous improvement in a highly regulated production environment serving aerospace, medical device, and other quality-critical industries. This role is ideal for a hands-on Manufacturing Engineer, Process Engineer, or Aerospace Manufacturing Engineer with experience in CNC machining, manufacturing process development, quality systems, and regulated standards such as AS9100 and ISO 13485. The engineer will work closely with production, quality, engineering, and operations teams to improve manufacturability, process capability, quality, cost, and on-time delivery.

Responsibilities:

• Develop, document, implement, and optimize manufacturing processes for precision-machined components used in aerospace, medical device, and other highly regulated applications.
• Create and improve manufacturing process plans, work instructions, routings, tooling strategies, fixtures, process documentation, and production methods for CNC machining operations.
• Support new product introduction, NPI, by reviewing engineering drawings, specifications, GD&T requirements, tolerances, materials, and customer requirements to establish robust manufacturing processes.
• Apply Design for Manufacturability, DFM, principles to identify production risks, recommend design or process improvements, and improve cost, quality, throughput, and repeatability.
• Lead continuous improvement initiatives using Lean Manufacturing, root cause analysis, corrective and preventive action, CAPA, 5 Why, process capability, and data-driven problem-solving methodologies.
• Partner with CNC programmers, machinists, quality engineers, inspectors, and production leadership to troubleshoot machining, tooling, dimensional, and process-related issues.
• Support process validation, first article inspection, FAI, process capability studies, PFMEA, control plans, and other quality documentation required for regulated manufacturing.
• Ensure manufacturing processes and documentation comply with applicable quality management systems and industry requirements, including AS9100, ISO 9001, ISO 13485, and customer-specific requirements.
• Analyze cycle times, scrap, rework, tooling performance, equipment utilization, and production data to identify opportunities for productivity improvement and cost reduction.
• Support investigations of nonconforming material and customer quality issues by determining root causes, implementing corrective actions, and verifying effectiveness.

Qualifications:

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a closely related engineering discipline.
• Professional experience in manufacturing engineering, process engineering, or production engineering within precision machining, aerospace manufacturing, medical device manufacturing, or another regulated manufacturing environment.
• Working knowledge of CNC machining processes, including milling, turning, cutting tools, fixtures, workholding, machining parameters, and precision manufacturing practices.
• Ability to interpret complex engineering drawings, specifications, geometric dimensioning and tolerancing, GD&T, and tight tolerance requirements.
• Experience developing manufacturing processes, work instructions, process routings, production documentation, and standardized manufacturing methods.
• Knowledge of regulated quality systems and standards such as AS9100, ISO 9001, ISO 13485, or comparable aerospace and medical device manufacturing requirements.
• Experience with root cause analysis, corrective action, CAPA, Lean Manufacturing, continuous improvement, and structured problem-solving techniques.
• Strong analytical and troubleshooting skills with the ability to work cross-functionally with manufacturing, quality, operations, engineering, and supply chain teams.

Desired Qualifications:

• Experience manufacturing complex, tight-tolerance components for aerospace, defense, aviation, medical device, surgical, or other highly regulated applications.
• Familiarity with aerospace first article inspection requirements, including AS9102, FAI documentation, traceability, and configuration-controlled manufacturing processes.
• Experience with medical device quality systems, process validation, risk management, PFMEA, control plans, and ISO 13485 requirements.
• Knowledge of CAD/CAM software, CNC programming, ERP/MRP systems, statistical process control, SPC, and manufacturing data analysis.
• Experience applying Lean, Six Sigma, Kaizen, 5S, value stream mapping, cycle-time reduction, and other operational excellence methodologies.
• Demonstrated ability to lead manufacturing improvement projects from problem identification through implementation, validation, documentation, and sustained production performance.