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PATIENTS' LIVES
Clinical Program Manager
Clinical & Regulatory
The Clinical Program Manager manages the full operational execution of clinical trials for Puzzle Medical Class II and III medical devices, with primary responsibility for site management, monitoring, and inspection readiness. Responsible for end-to-end delivery of studies from Early Feasibility Studies (EFS) through pivotal trials, including hands-on monitoring in early phases and scaling clinical operations through CRA and CRO management for later-stage studies. Ensures trials are executed on time, within budget, and in compliance with ICH-GCP, ISO 14155, and applicable regulatory requirements.
Quality Assurance Specialist
Quality
The Quality Assurance Specialist is responsible for reviewing and ensuring the completeness, accuracy, traceability, and compliance of manufacturing and production quality control documentation throughout the product lifecycle—from incoming inspection to final batch release. This role plays a key part in maintaining product quality and regulatory compliance by reviewing Job Travelers, Device History Records (DHRs), inspection records, manufacturing documentation, metrology reports, machine shop documentation, and cleanroom records.
Supplier Quality Specialist
The Supplier Quality Specialist is responsible for managing, evaluating, and monitoring supplier quality performance within a regulated Class III medical device environment in compliance with ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820/QMSR, and internal quality system requirements.
This role plays a critical part in supplier qualification, supplier audits, nonconformance management, CAPA activities, supplier change control, and continuous improvement initiatives to ensure product safety, compliance, and reliability.
Quality
Director of Operations
The Director of Operations will be responsible for coordinating and optimizing the company’s production activities and manufacturing operations. This person will play a key role in managing strategic external suppliers, production planning, the development of manufacturing infrastructure, and the execution of cleanroom operations.
Operations
Project Manager
The Project Manager is responsible for developing the Production Plan and monitoring the progress of activities required for the various stages of production readiness. They coordinate stakeholders, ensure adherence to timelines, and verify that deliverables, action items, and checklists are completed in accordance with established processes.
Operations
Assembly Technician
Cleanroom
The Assembly Technician at Puzzle Medical Devices assembles and tests medical devices to ensure they meet quality and safety standards. This role involves precise assembly work, following detailed procedures, and collaborating with engineering and quality teams to troubleshoot and improve processes. The ideal candidate is detail-oriented with hands-on assembly experience and a commitment to high standards in a regulated environment.
Metrology Technician
Machine Shop
Puzzle Medical Devices is seeking a Metrology Technician to join our team. This role is critical to ensuring the accuracy, reliability, and quality of components and assemblies used in our medical devices. The Metrologist will perform precision measurements, inspections, and analyses of components, prototypes, and production parts, supporting product development, manufacturing, and quality assurance activities. The successful candidate will help maintain high standards of dimensional and visual specifications while contributing to continuous improvement initiatives across the organization.
Quality Technician
Quality
The Quality Technician - Incoming Inspection is responsible for ensuring the quality and compliance of incoming materials, components, and subassemblies through inspection, documentation review, and disposition activities. This role supports the identification and resolution of quality issues, collaborates with cross-functional teams and suppliers to drive continuous improvement, and maintains compliance with the Quality Management System and applicable regulatory requirements, including ISO 13485 and FDA regulations.