Medical Assembly

Technical Line Lead – Medical Devices at Johnson ElectricLocation: 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 HereRecognition 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 DoingPerforming and overseeing assembly of wearable medical devices in accordance with approved work instructions, Device Master Records (DMRs), and quality system proceduresAssigning production operators to tasks, balancing workloads, and coordinating quick changeovers while maintaining quality and traceabilityTraining 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 policiesVerifying adherence to Good Documentation Practices (GDP), including accurate and timely completion of production recordsEnforcing safety standards, lean manufacturing principles, and 5S workplace organizationMonitoring production performance to maximize efficiency, minimize waste, and support on?time delivery targetsIdentifying, documenting, and escalating quality issues, non?conformances, equipment concerns, and resource needs to the SupervisorSupporting corrective and preventive actions (CAPA), root cause analysis, and continuous improvement initiativesParticipating in and recommending GK (continuous improvement) activities to enhance quality, efficiency, and complianceActively performing hands?on line work to maintain production flow, troubleshoot issues, and meet production commitmentsWhat We're Looking For2–3 years of experience working in medical device manufacturing2–3 years of experience in a Line Lead or leadership roleMinimum 1 year of experience working in compliance with FDA regulationsStrong attention to detail and commitment to quality and documentation accuracyAbility to understand, follow, and train others on technical assembly processes and quality standardsProven ability to lead by example and support a compliant, quality?focused cultureStrong problem?solving and analytical skillsComfort working in regulated environments with GMP and GDP requirementsKey CompetenciesLeadership and team supportTechnical capability and process understandingAttention to detail and thoroughnessProblem solving and root cause analysisRegulatory and quality compliance awarenessWork EnvironmentClimate?controlled medical device manufacturing environmentStrict adherence to cleanliness, safety, GMP, and regulatory standardsHands?on production floor roleCome join our global, inclusive & diverse teamOur 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.