Technical Line Lead - Medical Devices

Join Our Team as a Technical Line Lead – Medical Devices at Johnson Electric!

Location:

Vandalia, OH (Onsite). Facility:
Medical Devices. Operations Department:
Production / Operations. Vacancy Type:
Existing Position. As our next Technical Production Line Lead – Medical Devices, you will lead and support manufacturing operations within an assigned production area dedicated to the assembly of FDA‑regulated wearable medical devices.

• Perform and oversee the assembly of wearable medical devices in accordance with approved work instructions, Device Master Records (DMRs), and quality system procedures.
• Assign production operators to tasks, balance workloads, and coordinate quick changeovers while maintaining quality and traceability.
• Train and coach production operators on manufacturing processes, equipment use, quality requirements, and Standard Operating Procedures (SOPs).
• Ensure compliance with FDA Quality System Regulations (21
  
  CFRPart
  820), ISO
  13485 requirements, and internal quality policies.
• Verify adherence to Good Documentation Practices (GDP), including accurate and timely completion of production records.
• Enforce safety standards, lean manufacturing principles, and 5S workplace organization.
• Monitor production performance to maximize efficiency, minimize waste, and support on‑time delivery targets.
• Identify, document, and escalating quality issues, non‑conformances, equipment concerns, and resource needs to the Supervisor.
• Support corrective and preventive actions (CAPA), root cause analysis, and continuous improvement initiatives.
• Participate in and recommend GK (continuous improvement) activities to enhance quality, efficiency, and compliance.
• Actively perform hands‑on line work to maintain production flow, troubleshoot issues, and meet production commitments.

• 2–3 years of experience working in medical device manufacturing.
• 2–3 years of experience in a Line Lead or leadership role.
• Minimum 1 year of experience working in compliance with FDA regulations.
• Strong attention to detail and commitment to quality and documentation accuracy.
• Ability to understand, follow, and train others on technical assembly processes and quality standards.
• Proven ability to lead by example and support a compliant, quality‑focused culture.
• Strong problem‑solving and analytical skills.
• Comfort working in regulated environments with GMP and GDP requirements.
• Leadership and team support.
• Technical capability and process understanding.
• Attention to detail and thoroughness.
• Problem solving and root cause analysis.
• Regulatory and quality compliance awareness.
• Works in climate‑controlled medical device manufacturing environment with strict adherence to cleanliness, safety, GMP, and regulatory standards.
• Hands‑on production floor role.