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Medical Device product Manager

Job in Irvine, Orange County, California, 92713, USA
Listing for: Katalyst CRO
Full Time position
Listed on 2026-01-24
Job specializations:
  • Engineering
    Manufacturing Engineer, Product Engineer
Job Description & How to Apply Below

Join to apply for the Medical Device product Manager role at Katalyst CRO

Roles & Responsibilities
  • Identifies, designs, and develops the necessary equipment related to new product development.
  • Studies the existing processes to implement improvements on new products.
  • Implementation of automation in process and tool.
  • Responsible for preparing and managing specifications.
  • Assists technicians and engineers with 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 judgment is required.
  • Experience with industrial automation, robotics, or precision instruments is a plus.
  • Strong experience with Solid Works / 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.
Seniority level

Associate

Employment type

Contract

Job function

Product Management and Marketing

Industries

Pharmaceutical Manufacturing

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