Project Manager

US-CA-Rancho Santa Margarita

Overview

As a Project Manager you will be responsible for working within the framework of a team and performing the following activities:


 



  • Work on products from conceptualization through realization by integrating with the Research and Development teams

  • Identify, manage and track a wide range of program objectives through proper time management, contingency planning, team organization, and coordination across multiple functional groups

  • Make a positive, meaningful impact on the healthcare industry

  • Create and maintain the project schedule, delegate deliverables and communicate with management on progress and setbacks

  • Gain deep understanding of internal standard operating procedures in order to successfully navigate the project

  • Interface with internal and external customers in order to meet various needs and advance the project forward

  • Learn about clinical needs and relevant surgical procedures to make meaningful products

  • Participate in FMEA activities

  • Lead project update meetings and cross-functional design review meetings, and keep all stakeholders apprised of accomplishments and setbacks

  • Execute a multitude of design control activities and create technical documentation as needed that follow good documentation practices and comply with standard operating procedures

  • Be a part of all facets of product development



  • Teach, guide and mentor other team members in your areas of expertise to help with technical development

  • Review technical documentation for accuracy and compliance

Position Requirements

This position requires the following skills and attributes:



  • 4 year degree in Engineering: Biomedical or Mechanical preferred

  • 3-5 years of experience in the medical device industry

  • Experience in FDA regulations and ISO quality systems

  • Exposure to FMEA, Test Method Validation, and Process Qualification

  • Experience with SolidWorks or similar package

  • Strong technical writing and documentation skills

  • Proficiency with Microsoft Project or similar program

  • Experience with SAP and/or PLM is preferred

  • Prioritize the success of the team over individual success



  • Ability to thrive in an environment with changes and uncertainty

  • Excellent organization, communication, and documentation skills

  • Ability to work independently to find solutions

  • Previous leadership experience, interest in future leadership opportunities, and the desire to grow with the company

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