Technical Project Manager

Job Title: Technical Project Manager (Medical Device) Location: Madison, WI (Onsite) Employment Type: Contract Job Summary We are seeking an experienced Technical Project Manager to join the Device Engineering & Operations team in Madison, WI. The Technical Project Manager will lead cross‑functional engineering projects involving sustaining engineering, product changes, and manufacturing fixture development. This role is responsible for driving projects from planning through execution while ensuring compliance with medical device design controls, quality standards, timelines, budgets, and regulatory requirements. The ideal candidate has experience managing both hardware and software engineering projects within a regulated medical device environment. Key Responsibilities Project Management Lead multiple sustaining engineering and manufacturing fixture development projects from initiation through completion. Develop and manage project plans, schedules, budgets, resource allocation, and project documentation. Identify project risks, develop mitigation plans, and ensure projects remain on schedule and within budget. Facilitate project meetings and provide regular status updates to stakeholders and leadership. Manage engineering change control and stage‑gate product development projects. Coordinate internal teams and external contractors to ensure successful project execution. Cross‑Functional Leadership Partner with Engineering, Product Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams. Serve as the primary point of contact for project communications and stakeholder updates. Drive collaboration across multiple functional groups to resolve technical and project‑related issues. Manage Engineering Change Orders (ECOs), product improvements, and component obsolescence activities. Support Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and continuous improvement initiatives. Drive product reliability improvements, design optimizations, and cost reduction projects. Manufacturing Support Oversee the design, development, validation, and implementation of manufacturing fixtures and tooling. Support process validation activities including IQ, OQ, and PQ. Ensure manufacturing fixtures comply with safety, ergonomic, quality, and regulatory requirements. Required Qualifications Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Computer Science, Engineering, or a related technical discipline. Minimum 3 years of project management experience within the medical device industry. Experience managing engineering projects involving hardware and software products. Strong understanding of FDA 21 CFR Part 820, Design Controls, ISO 13485, GMP, and quality systems. Experience with engineering change management and sustaining engineering projects. Proficiency with project management tools such as Microsoft Project, Smartsheet, or Jira. Excellent leadership, communication, organizational, and problem‑solving skills. Preferred Qualifications Experience supporting manufacturing engineering and fixture/tooling development. PMP Certification or equivalent project management certification. Familiarity with CAD software and fixture design principles. Experience supporting process validation activities (IQ/OQ/PQ). #J-18808-Ljbffr VIVOS Professional Services, LLC