Jobs at Confluent Medical Technologies, Inc.

Manage medical device projects from scoping to execution, focusing on budgeting, risk management, and stakeholder communication. Lead teams through a product development process and ensure strong customer relationships.

The Senior Staff Process Development Engineer oversees manufacturing line design, capacity analysis, and process validation while leading cross-site initiatives and mentoring junior engineers.

The role involves developing textile-based medical structures, leading technical projects, and collaborating with teams for process improvement and validation. Hands-on work is required along with writing SOPs and managing multiple projects.

Lead and manage medical device product development projects through the Stage Gate process. Scope, plan, track schedules, budgets, risks, and metrics; run cross-functional meetings; present project status to stakeholders; build customer relationships; and manage multiple projects with up to 20% travel.

The Senior Manufacturing Engineer manages production processes, ensures compliance, leads teams, optimizes manufacturing methods, and resolves quality issues in a medical device environment.

Lead development and optimization of manufacturing processes for complex catheters, perform process validation (IQ/OQ/PQ), conduct statistical studies (DOE, ANOVA, Ppk), design fixtures and semi-automated equipment, support NPI and cost-reduction projects, troubleshoot production, create work instructions and reports, mentor engineers, and participate in quality investigations (NCRs, CAPAs).

Lead and develop the Quality Control team overseeing incoming, in-process, and final inspections for medical device components. Manage documentation, NCRs, supplier/customer QA coordination, audits, continuous improvement, staffing, training, and production support to ensure compliance with quality standards and regulatory requirements.

Lead supplier quality efforts including internal and supplier audits, SCAR/CAPA administration, ETQ Reliance supplier module administration, corrective action management, regulatory support (510(k)/Design Dossier), training, compliance metric reporting, and continuous improvement to maintain GMP/QSR/ISO compliance.

Leads the sales organization and commercial strategy for a medical-device manufacturing portfolio. Owns revenue growth, profitability, pipeline development, forecasting, strategic accounts, negotiations, market expansion, and sales performance. Develops Sales Directors and builds high-performing teams while partnering cross-functionally with executive, engineering, operations, quality, finance, legal, and marketing leaders. Represents the company with strategic customers and industry stakeholders and travels approximately 50% of the time.

Supervise and organize daily production activities to meet schedules and quality standards. Hire, train, evaluate and discipline staff; ensure compliance with safety, environmental and quality systems. Lead process improvements, Lean events, corrective actions and production planning; maintain clean, safe work environment and enforce organizational standards.

The Staff Quality Engineer ensures compliance to standards in medical device projects, supporting product development and manufacturing through quality assurance practices, statistical analysis, and risk management.

Manufactures medical device balloons according to specifications in a fast-paced production environment. Follows drawings, work instructions, GMP requirements, and production documentation; completes process logs accurately; manages multiple responsibilities; communicates issues; and performs tasks independently. Requires computer proficiency, flexibility with work shifts, strong attention to detail, and the ability to stand, walk, and lift up to 50 pounds.

Lead production planning, inventory control, and process improvements for medical device manufacturing. Develop and validate production methods, design fixtures and line layouts, conduct root cause analysis and time studies, support product transfers and new product introductions, and ensure compliance with quality and regulatory requirements.

Develop and validate laser-based manufacturing processes from prototype to production. Run and troubleshoot lasers, translate drawings into laser programs using CAD, perform statistical analysis (DOE, CPK/PPK, ANOVA), create quality documentation, provide production support, and follow safety and maintenance protocols in a medical device environment.

Lead and execute quality assurance and validation activities for manufacturing processes, including process/test method/software validation, supplier management, audits, CAPA, PFMEA, and corrective actions. Provide technical guidance, develop quality standards and protocols, drive documentation and process changes, and participate in cross-functional transfer and improvement projects. Supervise staff and act as Quality Manager as required.

Perform quality assurance tasks for medical device manufacturing including developing and maintaining quality standards, inspection and testing procedures, analyzing returned products, managing supplier corrective actions, supporting audits and validations, coordinating transfers and validation strategy, and ensuring regulatory and safety compliance.

Operate and manufacture medical device balloons to specification; follow work procedures, product drawings, and GMP documentation; perform physical tasks (standing, lifting up to 50 lbs); use basic computer systems; prioritize tasks, communicate issues to supervisors, and work flexible shifts in a fast-paced manufacturing environment.

Support and sustain validated manufacturing processes by providing tooling, fixtures, documentation, process controls, and production support. Lead investigations, root cause analysis, change control implementation, yield and scrap reduction, time studies, line balancing, and continuous improvement. Collaborate with Operations, Quality, Regulatory, and R&D to validate, transfer, and optimize production lines while maintaining compliance and manufacturing documentation.

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.

Support and sustain validated manufacturing processes by documenting changes, managing tooling/fixtures, conducting root-cause investigations, driving yield and efficiency improvements, implementing change controls, and supporting production line setup, transfers, and compliance activities in a regulated manufacturing environment.