Production Lead - Medical Device Manufacturing (Mandarin Required)

Job Description

Job Description

Overview: Production Lead - Medical Device Manufacturing (Mandarin Required):

The Production Lead - Medical Device Manufacturing (Mandarin Required) is responsible for overseeing daily electronics medical device manufacturing operations, including electronic assembly, PCB assembly, soldering, inspection, testing, packaging, and related production activities. This role ensures production is performed safely, efficiently, and in compliance with applicable quality system requirements, including ISO 13485 and FDA Quality Management System Regulation expectations.

Key Responsibilities: Production Lead - Medical Device Manufacturing (Mandarin Required):

• Supervise, coach, and support production employees in electronics medical device assembly, PCBA assembly, cable and wire harness assembly, soldering, inspection, functional testing, packaging, labeling, and related manufacturing activities.
• Plan and assign daily work, organize workflow, and monitor production schedules to meet customer demand, internal delivery commitments, and production priorities.
• Ensure production activities are performed according to approved procedures, work instructions, device history record requirements, bills of materials, assembly drawings, quality plans, and controlled documentation.
• Promote compliance with ISO 13485, FDA QMSR/21 CFR Part 820, Good Documentation Practices, Good Manufacturing Practices, ESD control requirements, and company quality system procedures.
• Ensure product identification, component traceability, material segregation, labeling, and lot or serial number control are maintained throughout production and material handling activities.
• Identify, document, and escalate nonconforming product, process deviations, failed tests, equipment concerns, calibration issues, and quality issues in accordance with company procedures.
• Support investigations, root cause analysis, corrective and preventive actions, process validation, test method validation, equipment qualification, and continuous improvement projects.
• Train new and existing employees on standard operating procedures, work instructions, ESD practices, controlled-environment requirements, safety requirements, and quality expectations.
• Verify accurate and timely completion of production records, device history records, line clearance documentation, inspection records, test records, rework records, shift reports, and other required manufacturing documentation.
• Promote a safe, clean, organized, and audit-ready production environment, including adherence to 5S, ESD controls, contamination control, calibration status checks, and proper handling of electronic components and finished devices.

Qualifications: Production Lead - Medical Device Manufacturing (Mandarin Required):

• High school diploma or equivalent required; associate degree or technical training in electronics, manufacturing, engineering, business, or a related field preferred.
• Minimum of 3 years of experience in a regulated manufacturing environment; electronics medical device manufacturing experience strongly preferred.
• Previous experience leading a small team, serving as a production lead, trainer, or acting supervisor is preferred; candidates with demonstrated leadership potential are encouraged to apply.
• Working knowledge of ISO 13485, FDA QMSR/21 CFR Part 820, Good Documentation Practices, Good Manufacturing Practices, nonconformance handling, and CAPA processes preferred.
• Basic understanding of ESD controls, traceability, production documentation, or quality records is preferred.
• Ability to read work instructions and production documents; willingness to learn assembly drawings and technical documentation.
• Basic computer proficiency, including Microsoft Office; ERP or MES experience is a plus.

Required Skills and Competencies: Production Lead - Medical Device Manufacturing (Mandarin Required):

• Good communication skills with the ability to reinforce procedures, documentation expectations, ESD requirements, workmanship standards, and quality requirements.
• High attention to detail and strong commitment to product quality, electrical reliability, and regulatory compliance.
• Sound judgment, problem-solving ability, and the ability to escalate production, test, equipment, material, or quality issues appropriately.
• Accountability for safety, quality, productivity, documentation accuracy, employee performance, test performance, and rework control.
• Proficiency in English and Mandarin Chinese is preferred to support communication with cross-functional teams and documentation, but is not required.

Work Environment and Physical Requirements: Production Lead - Medical Device Manufacturing (Mandarin Required):

• Work is performed in electronics medical device manufacturing, PCBA assembly, inspection, testing, packaging, warehouse, or controlled production environment.
• May require use of ESD smocks, wrist straps, heel straps, grounding devices, personal protective equipment, gowning, contamination control practices requirements.
• May involve proximity to soldering, small electronic components, test fixtures, calibrated equipment, hand tools, magnification equipment, and production test systems.
• May require standing, walking, bending, lifting, sitting at production stations, and moving throughout the production floor for extended periods.
• Must follow all safety, quality, hygiene, ESD, calibration, and controlled-environment requirements.