Project Manager, Operations Manager, Program ​/ Project Manager

• This position is responsible for managing all aspects of a project, including product design, development, design verification, and process validation with a focus on innovative catheter-based medical devices that address customer needs and meet business objectives. The Project Manager plans, organizes, and leads project team members to execute new product development and transfer to manufacturing projects. This role complies with FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Responsible and accountable for execution of R&D and NPI development and/or manufacturing transfer projects that deliver critical and strategic business benefits
• Serve as primary point of contact for external customers as well as internal stakeholders to proactively communicate project status, schedule, risks, and issue resolution
• Coordinates to define project needs and develop project scope and work plans for multiple concurrent projects that are typically moderate in complexity, and medium in size, scope, budget and/or impact to the business.
• Communicate with all levels of the organization from the production floor to upper management to ensure clear visibility to project health and overall alignment with project objectives
• Utilizes the Project Management Office (PMO) Toolbox to properly scope activities, manage risk, and monitor financial performance
• Lead project teams through the CathX Product Development Process (PDP), including Phase Gate reviews and other business processes
• Analyzes issues or problems related to planning, implementing, or completing project work, develops, and implements solutions.
• Work closely with functional management to ensure resources are allocated and effective on projects
• Creates a positive and productive team environment; generates organizational excitement for project benefits
• Travel to other CathX facilities, customer sites, and vendors as needed
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
• Performs other duties assigned as needed.

SUPERVISOR RESPONSIBILITIES:

• The position does not have supervisor responsibilities.

• Bachelor’s degree in Mechanical, Industrial, Manufacturing, Biomedical or related Engineering field, or equivalent experience at management discretion
• At least 3 years’ relevant Engineering or Project Management experience in a medical device manufacturing environment, or equivalent experience at management discretion
• Experience working in a highly regulated environment
• Knowledge of catheter construction techniques, materials, and manufacturing methods is preferred
• Basic knowledge of Project Management tools such as Microsoft Project, Visio, PowerPoint, etc.
• Basic knowledge of Project Management principles as defined by PMBOK
• Experience with statistical analysis and design of experiments (DOE) preferred.
• Knowledge of Good Manufacturing Process and Good Documentation Practice is preferred.

COMPENTENCIES:

To perform the job successfully, an individual should demonstrate the following competencies:

• Excellent verbal and written communication skills
• Good organizational skills
• Provide excellent and courteous customer service, establish, and maintain effective working relationships.
• Manage multiple concurrent project activities that often have competing timelines and deadlines.
• Maintain cooperative relationships with co-workers and others contacted through the course of work; respond in a positive manner to supervision and attend and perform duties on a regular and consistent basis.
• Ability to navigate ambiguity
• Ability to manage tight timelines and changing priorities
• Excellent problem-solving techniques
• Proficient with Microsoft office applications
• Ability to influence others indirectly
• Skilled at providing technical leadership on cross-functional teams

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities…