Technical Line Lead - Medical Devices

100249 Saia-Burgess LLC; Vandalia (MO); On-site; USD 75,000 - 110,000; Full time

Job summary

Johnson Electric is seeking a Technical Production Line Lead – Medical Devices in Vandalia, OH to lead assembly of FDA‑regulated wearable devices on the production floor, ensuring quality and on‑time delivery.

You will balance hands‑on manufacturing with floor leadership, training operators, enforcing GMP, GDP, 21 CFR Part 820, and ISO 13485, and driving continuous improvement.

Qualifications

• 2–3 years of experience in medical device manufacturing.
• 2–3 years in a Line Lead or leadership role.
• Experience working with FDA regulations and quality systems.
• Strong attention to detail and commitment to quality/documentation accuracy.
• Ability to train others on manufacturing processes and quality standards.
• Familiarity with GMP/GDP requirements and 21 CFR Part 820/ISO 13485.

Responsibilities

• Oversee assembly of wearable medical devices following approved work instructions and quality systems.
• Assign operators to tasks, balance workloads, and coordinate changeovers while ensuring quality and traceability.
• Train and coach operators on manufacturing processes, equipment use, and SOPs.
• Ensure compliance with FDA QSR, ISO 13485, and internal quality policies.
• Verify production records and maintain GDP and quality documentation.
• Enforce safety, lean principles, and 5S on the production floor.
• Monitor performance to maximize efficiency and on‑time delivery targets.
• Escalate quality issues, non‑conformances, and equipment concerns as needed.
• Support CAPA, root cause analysis, and continuous improvement initiatives.

Skills

Leadership

Problem solving

Attention to detail

Regulatory compliance awareness

Training and mentoring

Job description

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.

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

• 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

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.

About Johnson Electric Group

The Johnson Electric Group is a global leader in electric motors, actuators, motion subsystems and related electro‑mechanical components. It serves a broad range of industries including Automotive, Smart Metering, Medical Devices, Business Equipment, Home Automation, Ventilation, White Goods, Power Tools, Lawn & Garden Equipment, Warehouse Automation, Liquid Cooling and Robotic joints. The Group is headquartered in Hong Kong and employs over 30,000 individuals in over 20 countries worldwide. Johnson Electric Holdings Limited is listed on The Stock Exchange of Hong Kong Limited (Stock Code: 179). For more information, visit johnsonelectric.com.