Technical Line Lead - Medical Devices

Johnson Electric•Vandalia, OH

1d•Onsite

About The Position

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. This role combines hands‑on technical production work with floor leadership, ensuring products are manufactured efficiently, accurately, and in full compliance with FDA regulations, ISO 13485, and internal quality system requirements.

Requirements

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

Nice To Haves

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

Responsibilities

Performing and overseeing assembly of wearable medical devices in accordance with approved work instructions, Device Master Records (DMRs), and quality system procedures
Assigning production operators to tasks, balancing workloads, and coordinating quick changeovers while maintaining quality and traceability
Training and coaching production operators on manufacturing processes, equipment use, quality requirements, and Standard Operating Procedures (SOPs)
Ensuring compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485 requirements, and internal quality policies
Verifying adherence to Good Documentation Practices (GDP), including accurate and timely completion of production records
Enforcing safety standards, lean manufacturing principles, and 5S workplace organization
Monitoring production performance to maximize efficiency, minimize waste, and support on‑time delivery targets
Identifying, documenting, and escalating quality issues, non‑conformances, equipment concerns, and resource needs to the Supervisor
Supporting corrective and preventive actions (CAPA), root cause analysis, and continuous improvement initiatives
Participating in and recommending GK (continuous improvement) activities to enhance quality, efficiency, and compliance
Actively performing hands‑on line work to maintain production flow, troubleshoot issues, and meet production commitments