10+ years in relevant roles (7+ years acceptable if leading significant projects in the medical device industry).
Strong project management experience within the medical device sector.
EP product line experience preferred (intracardiac, catheter development).
Software development experience is a plus.
Education Required:
Bachelor's degree in a relevant discipline (Software Development Engineering or Mechanical Engineering preferred; sciences acceptable with relevant experience).
Key Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Executes project management tasks ensuring compliance with Design Control and Change Control policies.
Manages project scope, time, quality, and cost.
Oversees moderately complex projects or multiple smaller projects with managerial support.
Ensures risk/reward assessments and communicates critical issues impacting product quality to management.
Establishes and maintains risk analysis to mitigate project risks.
Translates project goals into actionable steps and ensures successful execution.
Coordinates with external vendors for co-developing equipment and software.