Project Manager - Medical Device Manufacturing

Job Title: Project Manager - Medical Device Manufacturing (Not Software) About the Role: We are seeking a Project Manager with deep experience in the medical device manufacturing space. This individual will take ownership of key product design transfer and manufacturing strategies for our innovative venous thromboembolism (VTE) clot removal products. You will play a critical role in delivering projects on time, within scope and budget, while maintaining compliance and quality excellence. This is not a software PM role - we are specifically seeking candidates with hardware-focused, medical device project experience. Key Responsibilities: Lead design transfer activities from R&D to production, ensuring timely, high-quality product launches. Drive manufacturing strategy execution, aligning cross-functional efforts with project goals. Manage project scope, timelines, milestones, budgets, and risks. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Supply Chain. Track and report progress to stakeholders and leadership, ensuring alignment and transparency. Improve project management tools, templates, and PMO governance practices. Manage and resolve team performance issues, workflow bottlenecks, and task prioritization. Review deliverables, perform quality spot-checks, and ensure compliance with regulatory standards. Own the project lifecycle using formal project management methodologies from initiation to closure. What You Bring: Bachelor's degree in Engineering (required). 6-8+ years of relevant project management experience. Strong background in the medical device industry, preferably with experience in design transfer and manufacturing operations. PMP or equivalent project management certification (preferred). Experience working with Change Orders (ECOs, ECRs) and document control systems. Exceptional communication, leadership, and organizational skills. Proficiency in risk management, stakeholder alignment, and resource planning. Ability to lead cross-functional teams with minimal supervision. Analytical thinking, sound judgment, and decision-making capability. Additional Details: This role is onsite in Irvine, CA Only candidates with medical device hardware experience will be considered No software-only PMs or generalist PMs