Manager, System & Test Engineering

Location:
Ft. Lauderdale, FL


Applicants: Click here to apply


Job Description:
The successful candidate for this position will lead the Systems Engineering and Test Engineering functions in a matrix development organization for the Platform Development group at Mako Surgical. The Systems Engineering function includes high-level design of Mako's surgical robotics product line and associated systems, requirements development, project leadership and hazard analysis. The Test Engineering function includes the development of test protocols, procedures, and tools to test conformance to requirements, as well as planning and executing the verification and validation testing.

Responsibilities:

• Manage the Systems Engineering function for RIO Platform projects, including Verification and Validation Testing at the systems level in collaboration with relevant program managers and project leaders
• Work with Program Managers and internal customers to negotiate requirements and schedules to align with resource constraints
• Lead the establishment of Best Practices for Systems Engineering, including requirements development, workflow analysis, project scheduling, hazard analysis (FMEA / FTA), system level design, testing processes, etc.
• Create and maintain project plans, budget reports, and other documents necessary to track and communicate projects and department status
• Coordinate and participate in the establishment of budget, priorities, and resource requirements for development projects
• Supervision, hiring, and firing responsibility for personnel on the team. Human Resource manager and supervisor shall be notified and consulted on decisions before any related action is taken
• Uphold the quality policies of the company
• Reports to Director of RIO Platform Development

• BS in Mechanical, Electrical or Biomedical Engineering and 7 years minimum experience in medical device product development or MS in Mechanical, Electrical or Biomedical Engineering and 5 years min. experience in medical device product development
• Minimum of 2 years experience supervising engineers and technicians in system engineering
• Demonstrated knowledge of electro-mechanical systems including cutting systems, control systems, motors, and actuators
• Demonstrated knowledge of requirements development and translating customer requirements into detailed system and component level requirements
• Experience with test protocol development and test report generation in a medical device environment
• Demonstrated knowledge of design control methods to support 21 CFR 820 / ISO 13485 regulations