Project Manager

The Project Manager is responsible for overseeing and managing all aspects of projects within the organization, ensuring that they are completed on time, within budget, and in alignment with organizational goals which includes leading the ISO 13485 implementation. This includes leading project teams, coordinating cross-functional work activities, managing project scopes, establishing compliant documentation processes, and ensuring successful delivery from inception to completion.

Job Details

• Position Type: Full-Time/Salaried (Exempt)
• Pay Range: Competitive (shared during interview)
• Work Location: Onsite - Menomonee Falls, Wisconsin
• Travel: None

Key Responsibilities

• Manage all phases of the project lifecycle, from initiation and planning to execution, monitoring, and project delivery, ensuring objectives are met.
• Define project scope, establish clear objectives, and create detailed project schedules, tracking milestones and progress against budget, timeline, and quality standards.
• Lead the implementation of ISO 13485 certification, including gap analysis, process development, and documentation establishment.
• Coordinate work activities across multiple functions and teams, ensuring smooth communication and collaboration for project success.
• Assist in selecting and negotiating with external consultants, vendors, and contractors, ensuring their activities align with project requirements.
• Regularly monitor and report on project performance, addressing any issues or risks, and providing timely updates to senior management and stakeholders.
• Ensure all project activities comply with organizational policies, regulatory requirements, and safety standards.
• Accurately complete project documentation, including reports, schedules, budgets, and scope changes, are maintained and communicated.
• Follow and enforce adherence to 5S standards for workplace organization and efficiency.
• Continuously identify opportunities to improve project management processes, team collaboration, and overall project outcomes.
• Perform all other duties as assigned.

Skills/Competencies

• Strong written and verbal communication skills.
• Strong knowledge of project management principles, methodologies, and tools. Proficient in managing project schedules, budgets, and resources.
• Knowledge of ISO 13485 quality management principles and medical devise lifecycle processes.
• Ability to work collaboratively with cross-functional teams, building positive relationships and fostering a team-oriented environment.
• Ability to identify challenges, develop solutions, and make informed decisions to keep projects on track.
• Strong analytical thinking with the ability to assess and interpret complex data to guide project direction.
• Excellent organizational and time-management skills, with the ability to prioritize tasks and meet deadlines in a fast-paced environment.

Qualifications (Required):

• Education: Bachelor's degree
• Experience: Minimum of 4 to 6 years of experience in project management, with a proven track record of managing projects from initiation to delivery.

Qualifications (Preferred):

• Certifications: Project Management Professional (PMP)
• Education: Bachelor's degree in Engineering

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