Medical Device product Manager

Job Title

Roles and 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:

• Identifies, designs, and develops the necessary equipment related to new product development.
• Studies the existing processes to implement improvements on new products.
• Implements 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 and 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.