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Project Manager

3 months ago

Sunnyvale, United States CathX Medical Full time
Job DescriptionJob DescriptionJOB OVERVIEW
  • 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 medical devices that address the customer needs for a complete procedural solution. The Project Manager plans, organizes, and directs engineering staff to meet company objectives for project management of new product development and transfer to manufacturing by performing the following duties personally or through This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:
  • Coordinates to define project needs and develop project scope and work plans for multiple concurrent projects that are typically moderate to high in complexity, and medium to large in size, scope, budget and/or impact.
  • Coordinates and maintains multiple concurrent project activities with the project team such as project templates, schedule, timelines, and host team meetings as needed.
  • Inspects project work for compliance with specifications, ECOs, and evaluates the results of the project to ensure the scope of work has been completed.
  • Analyzes issues or problems related to planning, implementing, or completing project work, develops, and implements solutions.
  • Assures that appropriate resources (personnel, tools, ) are available for achievement of Project objectives and timelines.
  • Support includes overall design, design for manufacturing, test method development, and product verification and validation testing.
  • Participate in technical discussions and decision making with cross functional
  • Interface between external vendors and core
  • Develop specifications, engineering blueprints and detail
  • Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
  • Provide design changes for existing Ensures proper documentation of changes.
  • Create engineering designs, develop plans and keep laboratory notebooks on all
  • Assist with testing; develop and utilize test protocols; generate written
  • Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
  • Responsible for supporting design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
  • Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
  • Responsible for communicating business related issues or opportunities to the next management
  • Performs other duties assigned as

SUPERVISOR RESPONSIBILITIES:
  • The position does not have supervisor

QUALIFICATIONS:
  • Bachelor's Degree in Mechanical, Industrial, Manufacturing, Biomedical Engineering or equivalent is
  • Must have three (3) plus years' relevant Engineering
  • Knowledge and experience in catheter design, development, and manufacturing
  • Experience with CAD software such as AutoCad or Solidworks is
  • Experience with project management tools such as Microsoft Project, Visio, PowerPoint,
  • Knowledge and experience in development processes and in documentation writing is
  • Experience with statistical analysis and design of experiments (DOE)
  • Ability to use PC and associated software is
  • In-depth knowledge of material and metals is
  • Knowledge of Good Manufacturing Process and Good Documentation Practice is

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
  • Provide excellent and courteous customer service, establish, and maintain effective working
  • Manage multiple concurrent project activities that often have competing timelines and
  • 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 work independently
  • Ability to manage tight timelines and changing priorities
  • Excellent problem -solving techniques
  • Proficient with Microsoft office applications
  • 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 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 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

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 Duties, responsibilities, and activities may change at any time with or without notice.


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