Senior Project Manager(Medical device) at Intellectt Inc

Job Title: Project Manager – Medical Devices

Location: New Richmond, WI

Job Description:

Key Responsibilities:

• Lead and manage end-to-end project lifecycle for medical device-related projects, ensuring alignment with organizational goals and objectives.
• Develop comprehensive project plans, including schedules, budgets, risk assessments, and resource allocations.
• Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory Affairs, to ensure seamless project execution.
• Monitor and control project progress, identifying risks and implementing mitigation strategies as needed.
• Ensure compliance with relevant regulatory requirements, such as FDA regulations, ISO 13485, and other applicable standards.
• Communicate project updates, milestones, and deliverables to stakeholders, both internal and external, effectively.
• Drive process improvements and implement best practices for project management methodologies.
• Foster a collaborative team environment, promoting accountability and high performance.
• Qualifications:Experience: Minimum of 10 years in project management, with at least 5 years in the medical device industry.
• Education: Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s degree preferred).
• Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and other medical device standards.