Project Manager

Responsibilities Lead development of accurate manufacturing cost models, make‑vs‑buy decisions, work‑center costs, and support quote generation and pricing strategy for new business or large sustaining initiatives. Establish, track, and report key performance metrics for development, project progression, and launch; champion continuous‑improvement and Lean/Six Sigma activities to boost quality, delivery, and cost. Gather and translate user, customer, clinician, and/or market needs and inputs into clear product and business requirements; present data‑driven recommendations to stakeholders. Maintain project documentation in line with internal procedures and notified‑body expectations, supporting audits and ensuring robust change‑control and traceability.Prepare reports and project summaries to communicate the status of projects on a regular basis. Provide technical and project‑management leadership, set priorities, allocate tasks, mentor team members, and foster a culture of efficiency, innovation, and regulatory excellence across the organization. Manage a few discrete projects with teams, operating within a defined PDP process delivering to achieve defined scope, schedule, and budget performance goals. Familiarity with and managing efforts for compliance with ISO standards, country‑specific (FDA, MDR, Health Canada, PMDA, etc.), GMP regulations, and customer requirements. Input and review for design history files, device master records, risk analyses, and validation protocols/reports (IQ/OQ/PQ) to ensure designs, processes, equipment, and products meet client, regulatory, and business needs. Qualifications Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field. 3+ years’ experience in Medical Device or related industry. 2+ years’ experience in leading teams in a manufacturing or engineering environment, with demonstrated experience of managing work within a project plan framework, including managing a schedule, budget, scope, progress, and reporting. Understanding of scientific principles and manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used. Demonstrated experience with formal problem‑solving methodologies, critical thinking, and deductive skills. Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971, and 45001. Knowledge of GMP principles and their application in medical device manufacturing, including country‑specific regulatory requirements (i.e., 21 CFR 820 in the United States, and EU MDR). Demonstrated experience using Lean/Six Sigma tools as necessary for new and continuous improvement projects. Demonstrated experience providing leadership and managing multiple projects of low to medium complexity. #J-18808-Ljbffr