Project Manager

Job Summary:

Under the direction of the Director of New Product Development, the Project Manager will oversee multiple projects from minor to mid-priority projects which often require considerable resources and high levels of functional integration. The Project Manager will own the project and lead the customer from original concept, through MPE’s design or transfer processes, to product launch. Maintaining and monitoring project plans, scheduling, budgeting, and expenditures is required to ensure that customer deadlines are being met in addition to delivering the expected project value to MPE. Overall, the ideal candidate would combine technical expertise in medical device development, regulatory knowledge, strong project management skills, and effective leadership abilities to successfully lead and deliver innovative projects in the medical device industry.

Essential Duties and Responsibilities:

• Responsibility for all aspects of the project over the entire project life cycle (initiate, plan, execute, monitor/control, close)
• Ensuring projects adhere to MPE processes and frameworks and all documentation is maintained appropriately for each project
• Assess project risks and issues and provide solutions where applicable
• Must be familiar with project scope and project objectives, as well as the role and function of each team member, to effectively coordinate the activities of the team
• Responsible for assembling the project team, assigning individual responsibilities, maintaining cost/budget activities, identifying appropriate resources needed, and developing schedule to ensure timely completion of project
• Concisely present project status and critical project risks to MPE leadership
• Determine project changes and ensuring deadlines are met
• Act as the main liaison between internal company personnel and customers for the main information channel
• 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

Education

• Bachelor’s degree in business, Engineering, or related field or equivalent experience
• Project management professional certification preferred

Experience and/or Training

• 5 years of experience in project management and new product development
• Experience in manufacturing and/or assembly
• Competency in Microsoft applications
• Experience with project Gantt creation software
• Knowledge of file management, transcription, and other administrative procedures
• Experience with phases of product development lifecycle, from concept ideation to commercialization
• Experience in medical device design or manufacturing industry
• Experience conducting risk assessments and developing risk management plans preferred
• Knowledge of ISO 13485, IEC 60601-1 standard, and FDA regulations preferred
• Experience with Smartsheets is a plus

Work Environment

• Standard office environment may need to go into production facilities which may not be climate controlled and the noise level is moderate.