Medical Device Project Manager

Job Title: MDR - Project Manager

Location:Mansfield, MA (Onsite)

Job Duration: 12 Months

Must Have:

·Ability to work with department peers and middle management within the marketing, engineering, and manufacturing functional groups.

·Experience with Project Management.

Nice to Have:

·Understanding of EU MDR regulation and remediation needs.

·Strong technical writing EUMDR Experience in the development of labeling for the medical device industry preferred.

:

·Responsibilities may include the following and other duties may be assigned.

·Responsible for the implementation of multiple EUMDR projects.

·A typical project includes updates to (labeling, IFU, packaging, BOMs, software, procedures/SOPs, product lifecycle management system, manufacturing resource management system, enterprise resource management system...).

·Requires the ability to work effectively with cross functional teams (Regulatory, Labeling, Packaging, Manufacturing, Engineering, Quality, Supplier Quality, Supply Chain, Planning...).

Project management experience within operations is preferred.

·Develops and manages all facets of the project(s) from intake through implementation and closure.

·Accountable for the successful implementation of the outcomes derived through the change through effective organization and leadership, business case and benefits management, risk management, issue resolution, planning and control, change management and quality management.

·Ensures the project adheres to all Corporate and IT policies and standards. Responsible for effectively managing the constraints of project management: Product, Schedule. Provides technical and analytical guidance and recommendations to leadership governance bodies.

·Keeps current on advances and best practices in project management methodologies.

·Oversees operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management.

·Assesses project issues and develops resolutions to meet productivity, quality, and client satisfaction goals and objectives.

·Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, and clients.

Differentiating Factors Autonomy:

·Receives assignments in task and objective oriented terms.

Organizational Impact:

·Establishes operational plans and implements policies and strategies.

·Decisions impact program schedules, customer satisfaction levels, or allocation of time and resources. Strive for continuous improvement and consistency in deliverables.

·Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult, and undefined, and require detailed information gathering, analysis and investigation to understand the problem.

Communication and Influence:

·Communicates with internal and external customers and vendors regarding ongoing operations.

·Uses information exchange, influence, and active persuasion without direct exercise of command to Product cooperation of other parties.

·May interact on issues that have externally shared objectives.

Required Knowledge and Experience:

·Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.

·Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a University Degree and minimum of 5 years relevant experience.