Program Manager Medical Device

Job Description: We are seeking a Program Manager to lead medical device development and maintenance projects and manage multiple projects across the board. You will be responsible for negotiating with clients, managing budgets, optimizing resources, and coordinating with cross-functional teams such as electrical, mechanical, systems, software, and quality engineers to ensure project deadlines are met and quality is improved. Key Responsibilities: * Program Management: Managing program budgets, tracking expenses, and efficiently utilizing resources. * Planning and Execution: Developing and organizing effective plans to achieve multiple objectives simultaneously. * Client Relations: Attending client meetings, preparing proposals, creating Statements of Work (SOWs), and developing delivery plans. * Resource Management: Forecasting resource needs and coordinating with functional managers to secure necessary personnel. * Stakeholder Management: Coordinating collaboration with internal and external stakeholders to promote project deadlines. * Cross-functional Collaboration: Working closely with teams such as electrical, mechanical, systems, software, and quality engineers. * Progress and Risk Management: Plan, track, and communicate project progress, risks, and challenges to stakeholders, leadership, and clients. * Problem Solving: Leverage strong analytical and problem-solving skills to resolve project challenges. Job Requirements: [Required (MUST)] * 14+ years of professional experience, including 3+ years as a program manager. * 5+ years of experience in medical device development or maintenance. * Experience in digital design, component engineering, board bringing-up, and PCB verification. * Experience with PLM (Product Lifecycle Management) tools or equivalent tools, and change management. * Fluent in Japanese and English communication skills. * Experience managing multiple projects simultaneously is a plus. * Excellent leadership, team-building, and interpersonal skills. * Excellent written, oral, presentation, and negotiation skills. * Proficiency in program management software (MS Project, Jira, Asana, Monday.com, etc.). [Preferred (WANT)] * PMP, PgMP, or equivalent program management certification. * Knowledge of medical device safety standards (IEC 60601), quality management standards (ISO 13485), and risk management standards (ISO 14971). * Knowledge of Medical Quality Management. * Experience with Agile/Scrum methodologies in a regulated environment.