Jobs at Confluent Medical Technologies, Inc.

Develops and validates manufacturing processes for complex medical-device catheters. Responsibilities include designing process parameters, tooling, fixtures, and semi-automated equipment; conducting DOE and statistical process studies; executing IQ/OQ/PQ validation; leading product introductions and process improvements; preparing engineering documentation; supporting quality investigations; and mentoring engineers.

Manufactures medical device balloons according to specifications in a fast-paced production environment. Responsibilities include following drawings, work instructions, process logs, and GMP procedures; completing documentation accurately; operating computer systems; managing multiple process responsibilities; communicating issues; and working independently. The role requires physical standing, walking, hand use, lifting up to 50 pounds, shift flexibility, and corrected or uncorrected 20/20 vision.

Leads process development from proof-of-concept prototypes through manufacturing validation and production implementation. Develops, optimizes, and validates processes; evaluates equipment and tooling; resolves issues through data analysis and root-cause investigation; conducts testing and experiments; documents results; supports capital requests and production training; and ensures safety, quality, environmental, and regulatory compliance. Provides technical guidance and supervises process development technicians.

Provides technical leadership for manufacturing process transfers into commercial production. Leads line setup, validation, startup, tooling and fixture implementation, process testing, data analysis, root-cause investigations, release testing, documentation, and cross-functional coordination. Drives continuous improvement, process optimization, capacity enhancement, and compliance with quality, safety, and regulatory requirements for medical device manufacturing.

Leads internal and cross-site quality system audits, customer inspections, CAPA assignments, audit reporting, and corrective action reviews. Prepares and presents Management Reviews, evaluates quality system performance, and drives improvements across training, CAPA, complaint, and supplier management systems. Provides compliance guidance, supervises a Quality Assurance Technician, directs audit teams, and interfaces with customers, regulatory agencies, and auditors. Requires medical device quality experience, ISO 13485 Lead Auditor certification, and knowledge of MDSAP and EU MDR.

Develops, optimizes, validates, and transfers surface processes for Nitinol medical devices, including microblasting, chemical etching, polishing, electropolishing, and cleaning. Uses statistical analysis, DOE, Lean, Six Sigma, root-cause investigation, and process data analysis to improve performance. Supports manufacturing transfer, validation, documentation, training, troubleshooting, and continuous improvement while collaborating with engineering, quality, manufacturing, and production teams.

Leads production associates in a medical device manufacturing environment, coordinating assignments, balancing workstations, maintaining productivity and quality, and supporting operator training and certification. Performs and oversees inspection, measurement, documentation, data entry, process compliance, equipment troubleshooting, and safety activities. Requires interpretation of technical documentation, engineering drawings, machine test results, and regulatory requirements. The role works in a cleanroom, supervises production associates, and may require varying shifts and overtime.

Develops, optimizes, validates, and transfers thermomechanical manufacturing processes for Nitinol medical devices. Responsibilities include designing precision fixtures and tooling, developing heat treatment and forming processes, conducting DOE and statistical analysis, investigating root causes, analyzing process data, supporting validation and manufacturing transfer, creating technical documentation, and driving continuous improvement. The role collaborates with manufacturing, quality, engineering, and operations teams while managing multiple technical priorities independently.

Leads a night-shift medical device manufacturing team, assigning work, balancing production lines, monitoring quality and productivity, and training operators. Performs complex production, inspection, measurement, documentation, and data-entry tasks while following work instructions, ISO/QSR requirements, and safety procedures. Troubleshoots basic equipment and software issues, maintains operator certifications, communicates with support teams, and participates in process and safety improvements.

Leads manufacturing operators on a night shift, coordinating assignments, training, certifications, production activities, quality inspections, documentation, and process troubleshooting for medical device production. Ensures productivity, quality, safety, regulatory compliance, workstation organization, and adequate process coverage. Uses measurement and inspection equipment, maintains records in manufacturing systems, communicates issues to support teams, and participates in process and safety improvements.

Leads production operators in a medical device manufacturing environment, coordinating schedules, workstation assignments, training, certifications, quality inspections, documentation, and productivity goals. Performs complex manufacturing and measurement tasks, resolves basic process and equipment issues, supports continuous improvement and safety activities, and ensures compliance with procedures and applicable regulations. Maintains operator coverage, mentors team members, communicates issues to support groups, and works a 12-hour daytime schedule from Wednesday through Saturday.

Leads medical device manufacturing operations on an overnight shift, supervising production associates, assigning work, balancing lines, and ensuring productivity and quality goals. Performs and oversees complex inspection and measurement processes, maintains manufacturing documentation, supports operator training and certifications, resolves basic equipment and process issues, and communicates with maintenance, IT, engineering, and supervision. Ensures compliance with safety, environmental, quality, and production procedures in a cleanroom environment.

Works on moderate-scope quality engineering problems and projects, analyzing situations and data, supporting equipment and task decisions, implementing design changes, and developing solutions to limited-scope issues. May handle broad assignments and provide technical guidance to lower-level personnel.

Leads complex, cross-functional medical device projects from proof of concept through production transfer. Manages scope, schedules, budgets, resources, risks, and Stage-Gate deliverables while coordinating technical teams and customer relationships. Presents project status, negotiates requirements, evaluates financial metrics, and applies medical device development, FDA, ISO, quality systems, design control, and statistical knowledge. The role requires technical leadership, customer-facing communication, and project management experience in a regulated environment.

Leads production associates in a medical device manufacturing environment. Coordinates staffing, schedules, training, certifications, process execution, quality inspections, documentation, and productivity targets. Performs complex manufacturing and measurement tasks, resolves basic equipment and system issues, supports process improvements, and ensures compliance with safety, environmental, QSR, ISO, and company procedures. Works Wednesday through Saturday, 6:00 a.m. to 6:00 p.m., with occasional travel and possible overtime.

Leads manufacturing operators in a medical-device production area, coordinating assignments, balancing workstations, meeting productivity and quality targets, and maintaining certified process coverage. Performs and oversees inspections, measurements, documentation, data entry, equipment troubleshooting, training, and safety compliance. Communicates issues to supervisors, maintenance, IT, and engineering while supporting process improvements and regulatory adherence. Works an overnight four-day schedule in a cleanroom environment.

Leads complex, cross-functional customer and internal programs from concept through commercialization. Responsibilities include developing integrated plans, managing scope, schedule, resources, budgets, risks, quality, and dependencies; leading governance and Stage Gate reviews; presenting executive updates; resolving conflicts; influencing teams without direct authority; and ensuring regulatory, quality, customer, and financial objectives are achieved across multiple functions and sites.

Leads manufacturing operators in a medical-device production environment. Assigns and reassigns work, maintains productivity and quality targets, supports complex process steps, trains and certifies operators, resolves basic equipment and process issues, performs inspections and measurements, completes production records, and follows safety, quality, regulatory, and environmental procedures. Requires hands-on technical production expertise, team supervision, documentation accuracy, and the ability to interpret engineering and manufacturing instructions.

Leads medical device manufacturing operations and supervises production associates. Assigns work, balances production lines, maintains operator certifications, supports quality and productivity goals, performs inspections and measurements, records manufacturing documentation, resolves basic equipment and process issues, and provides training and coaching. Ensures compliance with work instructions, QSR, ISO, safety, and environmental procedures while supporting process improvement activities.

Lead medical-device manufacturing operations and supervise production associates. Coordinate staffing, workstation assignments, training certifications, quality inspections, documentation, data collection, and productivity goals. Perform complex manufacturing and measurement processes, resolve basic equipment and system issues, communicate production concerns, and ensure compliance with work instructions, safety procedures, QSR, ISO, and environmental requirements in a cleanroom setting.