Project Manager (Direct Hire)
Milwaukee, WI
7775
100-125k
Description for Project Manager:
Reporting to the Director of New Product Development within the Project Management Office (PMO), the Project Manager oversees multiple minor to mid-priority medical device projects that often require considerable resources and high levels of functional integration. The Project Manager owns each project and leads the customer from original concept, through our design or transfer processes, to product launch, maintaining and monitoring project plans, schedules, budgets, and expenditures to meet customer deadlines and deliver expected project value. The ideal candidate combines technical expertise in medical device development, regulatory knowledge, strong project management skills, and effective leadership to successfully deliver innovative projects in the medical device industry.
Responsibilities for Project Manager:
• Take responsibility for all aspects of the project over the entire project life cycle (initiate, plan, execute, monitor/control, close).
• Lead customers from original concept through design or transfer processes to product launch.
• Ensure projects adhere to company processes and frameworks, and that all project documentation is maintained appropriately.
• Assemble the project team, assign individual responsibilities, identify needed resources, and develop schedules to ensure timely project completion.
• Maintain and monitor project plans, scheduling, budgeting, cost, and expenditures to meet customer deadlines and deliver expected project value.
• Understand project scope, objectives, and each team member’s role and function to effectively coordinate team activities.
• Assess project risks and issues, and provide solutions where applicable.
• Determine project changes and ensure deadlines are met.
• Concisely present project status and critical project risks to leadership.
• Act as the main liaison and primary information channel between internal personnel and customers.
• Understand business implications and financial considerations related to medical device project management.
• Participate in relevant professional development activities, workshops, and conferences.
• Follow and comply with all safety and work rules and regulations.
Requirements for Project Manager:
• Bachelor’s degree in Business, Engineering, or a related field, or equivalent experience.
• Project Management Professional (PMP) certification preferred.
• 5 years of experience in project management and new product development.
• Experience in medical device design or manufacturing industry.
• Experience in manufacturing and/or assembly.
• Experience with phases of the product development lifecycle, from concept ideation to commercialization.
• Competency in Microsoft applications.
• Experience with project Gantt creation software.
• Knowledge of file management, transcription, and other administrative procedures.
• Experience conducting risk assessments and developing risk management plans preferred.
• Knowledge of ISO 13485, IEC 60601-1, and FDA regulations preferred.
• Experience with Smartsheet is a plus.
• Standard office environment with time in production facilities that may not be climate controlled and have moderate noise levels.
Benefits:
- Health insurance
- Dental insurance
- 401k with matching
- PTO
- Paid holidays
