Medical Assembly

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 Come join our global, inclusive & diverse team Our purpose is to improve the quality of life of everyone we touch through our innovative motion systems. We are a truly global team bound together by our shared values. Our culture is built on the diversity, knowledge, skills, creativity, and talents that each employee brings to the company. Our people are our company's most valuable asset. We are committed to providing an inclusive, diverse and equitable workplace where employees of different backgrounds feel valued and respected, regardless of their age, gender, race, ethnicity or religious background. We are committed to inspiring our employees to grow, act with ownership and find fulfilment and meaning in the work they do.