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Medical Device product Manager
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-01-24
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.
- 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.
Associate
Employment typeContract
Job functionProduct Management and Marketing
IndustriesPharmaceutical Manufacturing
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