Project Manager

This position is responsible for managing all aspects of customer projects, 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). Responsibilities 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 Qualifications 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. SUPERVISOR RESPONSIBILITIES: The position does not have supervisor responsibilities. COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies: Values: Integrity, Accountability, Teamwork, Innovation Excellent verbal and written communication skills Good organization skills Ability to create and maintain effective working relationships across all levels of the organization Manage multiple concurrent project activities that often have competing timelines and deadlines. Excellent problem-solving techniques Broad understanding of manufacturing processes that are common in medical devices, including both metals and polymers Comfortable navigating ambiguity and managing change Ability to influence others indirectly Advanced knowledge of Project Management tools such as Microsoft Project, Visio, Excel, PowerPoint, etc. Skilled at providing technical leadership on cross-functional teams PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work env ronment 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 to perform the essential functions. PHYSICAL DEMANDS: Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes. WORK ENVIRONMENT: Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing protection. TRAVEL: This position may require 10-25% travel between sites and customer or supplier locations as required, depending on the needs of the organization. OTHER DUTIES: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Salary range: $110,000 - $130,000 Apply here: