Lead Manufacturing Engineer

Role details

We are hiring for a Manufacturing Lead opportunity with a medical device manufacturing client in Southington, CT (onsite), supporting manufacturing engineering, process improvement, production support, automation, injection molding, assembly processes, and continuous improvement within a regulated manufacturing environment.

Position: Manufacturing Lead/Supervisor

Location: Southington, CT (Onsite)

Experience: 7+ Years

Key Responsibilities

• Provide technical leadership and manufacturing engineering support for assigned production lines and manufacturing processes.
• Lead continuous improvement and process optimization initiatives to improve yield, quality, cycle time, productivity, and equipment reliability.
• Lead and support CAPA, root cause analysis, corrective actions, and process improvement activities.
• Serve as a technical resource for manufacturing processes, equipment, automation, and production issues.
• Lead engineering projects from concept through implementation while meeting quality, schedule, and budget requirements.
• Support the development, implementation, and optimization of plastic injection molding, assembly, automation, and process control systems.
• Partner with Quality Engineering on equipment qualification, process validation, and process changes.
• Apply Six Sigma methodologies and tools, including DOE, Process Capability, and Gage R&R.
• Identify opportunities to reduce scrap, downtime, process variation, and manufacturing costs.
• Support evaluation, selection, installation, commissioning, and qualification of new equipment, automation, tooling, and manufacturing processes.
• Ensure manufacturing processes comply with applicable FDA QSR and medical device quality requirements.

Required Qualifications

• Bachelor’s degree in engineering, Engineering Technology, Manufacturing Engineering, Mechanical Engineering, or a related STEM discipline.
• 5+ years of Manufacturing Engineering experience, preferably within a medical device or other regulated manufacturing environment.
• Strong experience with manufacturing process improvement and production support.
• Knowledge of Six Sigma methodologies and tools, including DOE, Process Capability, and Gage R&R.
• Hands-on experience with automation, plastic injection molding, assembly processes, and process controls.
• Experience with CAPA, root cause analysis, corrective actions, and process validation.
• Familiarity with FDA QSR and regulated medical device manufacturing requirements.
• Working knowledge of SolidWorks for drawing interpretation and assembly-related activities.
• Strong technical documentation, analytical, troubleshooting, and problem-solving skills.
• Demonstrated ability to lead projects and collaborate effectively with cross-functional teams.