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PATIENTS' LIVES
Clinical Research Associate
The Clinical Research Associate manages the full operational execution of clinical trials for Puzzle Medical Class III medical devices, with primary responsibility for site management, monitoring, and inspection readiness. Responsible for end-to-end delivery of Early Feasibility Studies (EFS), acting as the primary CRA and performing all monitoring activities hands-on. Ensures trials are executed on time, within budget, and in compliance with ICH-GCP, ISO 14155, and applicable regulatory requirements.
Clinical & Regulatory
Metrologist
Machine Shop
Puzzle Medical Devices is seeking a Metrologist 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 Control Technician
Quality
Puzzle Medical Devices is seeking a Quality Control Technician to join our team. This QC Technician performs in-process and final inspections of implantable medical devices within ISO-classified cleanroom environments to ensure compliance with specifications and regulatory requirements. They also review manufacturing records (DHRs) to verify accuracy and adherence to Good Documentation Practices, and ensure that nonconformances and corrective actions are properly documented.
Process Engineer
Mechanical Design
The Process Engineer develops and optimizes manufacturing processes, from early prototyping through production scale-up. He/she will work closely with the engineering team to build robust, efficient processes that meet the demands of a regulated medical device environment.
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.