Jobs at Confluent Medical Technologies, Inc.

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 medical-device manufacturing activities and supervises production associates across a 4x3 daytime shift. Assigns work, balances production lines, monitors productivity and quality, maintains operator certifications, provides training and coaching, performs inspections and measurements, completes manufacturing records, and resolves basic process, equipment, IT, and system issues. Ensures compliance with safety, environmental, quality, QSR, ISO, and company procedures while supporting process improvement activities.

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 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.

Leads medical device process development for catheters, balloons, and polymer extrusion. Responsibilities include process analysis, optimization, validation, characterization studies, DOE, tooling and parameter design, design control documentation, new product introduction, cost reduction, and manufacturing quality improvement. The role also creates technical documentation, supports cross-functional projects, mentors engineers, conducts design reviews, and coordinates engineering work for moderate-to-major projects.

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.

Develops and maintains quality standards for medical device materials, products, and manufacturing processes. Designs inspections and testing methods, analyzes quality data and nonconformances, leads root-cause investigations, manages supplier quality activities, and supports corrective actions. Prepares validation and quality documentation, supports audits and product or process transfers, communicates with customers and regulatory agencies, and provides technical guidance to quality personnel while ensuring regulatory, safety, and HSE compliance.

Supports quality engineering for medical device materials, products, and manufacturing processes. Responsibilities include developing quality standards, inspection and testing methods, data and nonconformance analysis, root cause investigations, corrective actions, supplier quality, validation documentation, audits, product and process transfers, design reviews, and regulatory compliance. The role also coordinates technicians, responds to stakeholder inquiries, and contributes to continuous improvement.

Leads quality assurance and validation activities for medical device manufacturing, including process and test method validations, supplier quality, CAPA, complaints, nonconformances, audits, risk management, change control, and product transfers. Analyzes quality data, supports continuous improvement, ensures regulatory and quality-system compliance, and provides technical guidance to technicians and cross-functional teams.

The Quality Assurance Engineer I develops and maintains quality standards, inspection and testing methods, validation strategies, and quality documentation for medical device manufacturing. Responsibilities include analyzing complaints and nonconformances, conducting root-cause investigations, managing supplier corrective actions, supporting audits, performing design reviews, responding to regulatory inquiries, and coordinating quality projects. The role requires cross-functional collaboration, technical guidance, regulatory compliance, and independent resolution of quality issues.

Manufactures medical device balloons according to specifications in a fast-paced production environment. Reads and completes drawings, work instructions, process logs, and other documentation while following GMP requirements. Prioritizes multiple responsibilities, communicates issues, works independently, and adapts to changing shifts. The role requires basic computer proficiency, attention to detail, frequent standing and walking, hand dexterity, lifting up to 50 pounds, and verified 20/20 vision.

Manufactures medical device balloons according to specifications, follows drawings and work instructions, completes production documentation, and adheres to GMP requirements. Prioritizes multiple process responsibilities, communicates issues, works independently, and adapts to changing shifts in a fast-paced manufacturing environment. The role requires attention to detail, basic computer proficiency, physical standing and walking, lifting up to 50 pounds, and 20/20 vision.

Support and optimize validated manufacturing processes and production lines through documentation, tooling and fixture management, change control, investigations, root-cause analysis, yield and scrap reduction, time studies, layout and capacity improvements, and cross-functional compliance activities. Act as engineering SME for floor decisions and support new product introductions and transfers.

Develop, revise, and maintain controlled technical documentation supporting medical device engineering, manufacturing, quality, and product lifecycle activities. Create operator-ready work instructions, inspection procedures, specifications, protocols, reports, ERP documentation, and risk records. Collaborate with engineers, technicians, Quality, Operations, Supply Chain, and Training to capture processes, standardize documentation, resolve gaps, and route records through approval and document-control workflows. Support manufacturing and process transfers, including operations in Costa Rica, while ensuring quality-system and regulatory compliance.

Coordinates production scheduling, capacity planning, materials requirements, purchasing, inventory control, production documentation, and customer delivery schedules for assigned product lines. Monitors production through shipment, improves production control processes, ensures regulatory and safety compliance, and supervises personnel. Requires independent judgment, analytical ability, strong communication skills, and proficiency with office and database tools.