Technical Line Lead Medical Devices at Johnson Electric
Location: Vandalia, OH (Onsite)
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.
Why You'll Love Working Here:
Recognition Programs: Programs that recognize and reward employee achievements and contributions.
Community Engagement: Opportunities to participate in community service and corporate social responsibility initiatives.
Strong Leadership: Work under experienced and visionary leaders who guide the company towards success.
Innovation Hubs: Access to state-of-the-art facilities and innovation hubs that foster creativity and development.
What You'll Be Doing:- 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
What We're Looking For:- 23 years of experience working in medical device manufacturing 23 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
Key Competencies:- 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
- Work Environment
- Climate?controlled medical device manufacturing environment
- Strict adherence to cleanliness, safety, GMP, and regulatory standards
- Hands?on production floor role
- Apply online at www.johnsonelectric.com We can't wait to meet you!
- Come join our global, inclusive & diverse team
