Project Manager - Medical Devices

Project Manager - Medical Devices 
Madison, WI 
Pay: $61.00 - $65.00 per hour 
26-07290

Job Summary

The Technical Project Manager is responsible for leading cross-functional engineering projects from planning through implementation, ensuring projects are completed on time, within budget, and in compliance with quality and regulatory requirements. This role manages technical product development, sustaining engineering, manufacturing fixture development, engineering change activities, and project execution while collaborating with engineering, quality, regulatory, manufacturing, and supply chain teams. The Technical Project Manager serves as the primary point of contact for project planning, risk management, stakeholder communication, and project delivery.

Job Responsibilities

• Lead multiple technical engineering projects from initiation through completion, including sustaining engineering and manufacturing fixture development initiatives.
• Develop and maintain project plans, schedules, budgets, resource allocations, and project documentation.
• Monitor project progress, identify risks, and implement mitigation plans to ensure successful project execution.
• Facilitate project meetings and provide regular status updates to stakeholders and leadership.
• Coordinate cross-functional teams, including Engineering, Product Development, Quality, Regulatory, Manufacturing, and Supply Chain.
• Serve as the primary point of contact for project communication, issue resolution, and stakeholder management.
• Manage engineering change orders, product updates, and product lifecycle activities.
• Support root cause investigations and corrective and preventive action (CAPA) activities.
• Drive product reliability improvements, cost reduction initiatives, and design optimization efforts.
• Oversee the design, validation, and implementation of manufacturing fixtures and tooling.
• Support equipment and process validation activities, including IQ, OQ, and PQ documentation.
• Coordinate work performed by external vendors and contract manufacturers.
• Ensure compliance with applicable regulatory requirements, quality standards, and design control processes.
• Participate in project budgeting and evaluate the impact of scope, schedule, and resource changes.
• Maintain accurate project documentation and ensure deliverables meet technical, quality, cost, and schedule objectives.

Job Requirements

• Minimum of 3 years of project management experience within the medical device or regulated manufacturing industry.
• Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Computer Science, or a related technical discipline.
• Experience leading technical product development, sustaining engineering, or manufacturing projects.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, design controls, and Good Manufacturing Practices (GMP).
• Experience managing engineering change orders (ECOs), risk assessments, and CAPA activities.
• Experience with manufacturing support, fixture development, or process improvement is preferred.
• Proficiency with project management software such as Microsoft Project, Smartsheet, or Jira.
• Strong project planning, budgeting, scheduling, and resource management skills.
• Excellent leadership, communication, organizational, and problem-solving skills.
• Ability to manage multiple concurrent projects in a fast-paced, cross-functional environment.
• PMP certification is preferred.
• Familiarity with CAD software and fixture design principles is preferred.