Project Manager - Medical Device - Billerica

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

• Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
• Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
• Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
• Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
• Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions * Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
• Supports project team in establishing and maintaining product requirements and test plans.
• Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
• Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
• Reliable, consistent and punctual attendance is an essential function of the job.
• Other duties as assigned. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.