Medical Device product Manager

1 week ago

Irvine, California, United States Katalyst Healthcares & Life Sciences Full time

Roles & Responsibilities:

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Client procedures and guidelines, the duties and responsibilities for this position are:

  • I dentifies, designs, and develops the necessary equipment related to new product development.
  • Studies the existing processes to implement improvements on new products.
  • Implement the automation in process and tool.
  • Responsible for preparing and managing specifications.
  • Assists technicians and engineers about unusual problems. Responsible for purchasing and designing equipment that meets safety and environmental requirements.
  • Performs activities of process/product validation.
  • Can supervise, coordinate, and technically revise the work of a limited group of technicians.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Performs other duties assigned as needed.

Education & Experience:

  • Knowledge and experience in product development/NPD is preferred.
  • Design and develop electro-mechanical systems and components.
  • Perform system integration of mechanical and electrical parts.
  • Identifying and using stepper motors, drivers, sensors using PLC programming in Design.
  • Under limited supervision Performs mechanical, electromechanical, developmental Design duties in New Product Development engineering, where some judgement is required.
  • Experience with industrial automation, robotics, or precision instruments is a plus.
  • Strong experience with SolidWorks / CAD software and GD&T.
  • Must possess knowledge of good manufacturing practices and documentation, preferably in the medical industry.
  • Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD and MDR.
  • Knowledge of statistical analysis and design of experiments (DOE) preferred.
  • Knowledge of Computer programs.
  • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills.
  • Personal computer skills, Microsoft Project, Windows: word processing, project planning, presentation, e-mail, web.

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