Job Title: Catheter Technician Lead (Full Time)
Reports to: CatheterManufacturing Engineering Manager
Pay: Starting at $40.00
POSITION OVERVIEW
The Catheter Technician Lead is responsible for leading the day-to-day activities of the catheter manufacturing team while remaining an active, hands-on contributor in the assembly of Adagio Medical's life-saving electrophysiology catheters. This role serves as the technical leader on the production floor, ensuring products are manufactured safely, efficiently, and in compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
This position requires exceptional technical aptitude, leadership skills, attention to detail, and the ability to build complex catheter assemblies while fostering a culture of quality, accountability, and continuous improvement.
ESSENTIAL DUTIES
- Leads daily manufacturing activities for the catheter production line to ensure production schedules, quality standards, and delivery commitments are achieved.
- Coordinates work assignments and production priorities with Manufacturing Supervisors and Manufacturing Engineering.
- Serves as the primary technical resource for Catheter Technicians during assembly operations.
- Provides floor support by resolving assembly issues, identifying bottlenecks, and escalating concerns appropriately.
- Assists supervisors with workload balancing and staffing priorities throughout the production shift.
- Leads shift start-up meetings and communicates production priorities, quality concerns, and safety topics.
- Performs advanced assembly of complex electrophysiology catheter systems using hand tools, fixtures, microscopes, precision measuring equipment, and specialized manufacturing processes.
- Performs catheter assembly operations including bonding, reflow, shaft preparation, braiding support, tip assembly, handle assembly, electrical connections, inspections, and functional testing.
- Performs product verification, calibration, inspections, and testing to ensure compliance with specifications.
- Builds prototype, engineering, pilot, verification, validation, and production units.
- Supports New Product Introduction (NPI), process validation builds, and Design Verification Testing (DVT).
- Trains, mentors, and certifies new Catheter Technicians on manufacturing procedures, workmanship standards, and Good Documentation Practices.
- Ensures technicians demonstrate competency before performing independent work.
- Reinforces adherence to Standard Operating Procedures (SOPs), work instructions, and manufacturing specifications.
- Coaches employees on workmanship, efficiency, quality expectations, and continuous improvement.
- Assists in developing standardized training materials and skills matrices.
- Promotes a "Quality First" culture throughout manufacturing.
- Ensures all work complies with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, applicable GMP requirements, and company Quality Management System procedures.
- Reviews Device History Records (DHRs), manufacturing documentation, and production records for completeness and accuracy.
- Assists with investigations involving nonconforming materials, CAPAs, deviations, and production issues.
- Performs in-process inspections and verifies product conformance to engineering drawings and specifications.
- Maintains strict adherence to cleanroom requirements and contamination control procedures.
- Identifies opportunities to improve safety, quality, productivity, throughput, and manufacturing efficiency.
- Supports Lean Manufacturing, 5S, visual management, and operational excellence initiatives.
- Participates in process validations, equipment qualifications, and manufacturing transfer activities.
- Assists Manufacturing Engineering with fixture development, process improvements, and documentation updates.
- Supports engineering builds, clinical builds, verification activities, and manufacturing transfers.
- Assists in inventory control, material shortages, and production readiness activities.
- Serves as the technical liaison between production personnel and engineering teams.
QUALIFICATIONS
- 7+ years of experience in regulated medical device manufacturing with at least 2 years assembling complex catheter-based medical devices.
- Demonstrated experience serving as a technical lead, trainer, mentor, or subject matter expert in manufacturing.
- Strong understanding of catheter manufacturing processes including precision assembly, bonding, inspection, testing, and documentation.
- Experience working under FDA Quality System Regulations, ISO 13485, GMP, and Good Documentation Practices.
- Strong understanding of quality systems, nonconformance management, CAPA support, and production documentation.
- Experience interpreting engineering drawings, specifications, and manufacturing procedures.
- Proficiency using microscopes, precision measuring equipment, fixtures, and inspection tools.
- Excellent communication, leadership, and organizational skills.
- Strong troubleshooting and problem-solving abilities.
- Demonstrated commitment to continuous improvement and operational excellence.
PHYSICAL REQUIREMENTS
This position is based in a manufacturing environment with low to moderately high noise levels. Work is performed in a Cleanroom environment, requiring the use of protective gear (gowns, gloves, hairnets, and masks). Ability to sit or stand for extended periods while performing repetitive assembly tasks. Occasional standing with the ability to traverse confined spaces and maneuver up to 25lbs required.
This employer participates in E-Verify, a federal program to confirm the employment eligibility of new hires. If you have any questions about the E-Verify process or your rights, please visit the E-Verify website or contact Human Resources.
Consistent with the Americans with Disabilities Act (ADA), CDPA, and FEHA, it is the policy of Adagio Medical to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for the company. The policy regarding requests for reasonable accommodation applies to all aspects of the hiring process. If reasonable accommodation is required, please contact [email protected].
Adagio Medical is committed to creating an inclusive and equitable workplace where all individuals are valued and receive equal opportunities for employment and advancement, regardless of their race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected status or characteristic.
Pay: From $40.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Experience:
- Catheter: 7 years (Preferred)
Ability to Commute:
- Laguna Hills, CA 92653 (Required)
Work Location: In person
