System Integration Engineer

Location:
Ft. Lauderdale, FL

Job Description:
MAKO Surgical Corp. is looking for a System Project Engineer with a strong background in the medical device industry to participate in the integration of an exciting new technology involving robotics, software, navigation, and orthopedic implants & instruments.

Responsibilities:

• Define, drive, and support execution of system design control activity and documentation as required – including but not limited to system level design inputs, risk analysis, verification, validation, and design reviews
• Assist in negotiations between engineering and internal customers to finalize product requirements
• Build and maintain system Project Design History File
• Participate in development and maintenance of project plans, as well as tracking cross-functional accomplishments of near term and extended objectives
• Coordinate work, priorities, and schedule with Program Manager. Assure timely and effective project completion according to the project plan and budget. Must be able and flexible to work well under changing priorities in a high energy, demanding environment
• Identify opportunities to compress the critical path and mitigate project conflicts
• Support development of subsystems and engineering activities as required. Apply sound engineering problem-solving techniques to product development and maintenance
• Support the design and development of system hardware including 3D models, 2D drawings, material selection, inspection requirements, and manufacturing process requirements
• Solicit input from engineering, sales, marketing, quality, operations, and external customers and partners in completing these activities
• Support system testing, verification, and validation, using sound engineering problem-solving techniques applied to mechanical testing and cadaver evaluations. Support development of testing strategy, protocols, reports, and data collection. Coordinate the activities required to fabricate test parts & fixtures
• Support QA/RA efforts as required (QS updates, CAPAS, 510(k) submissions, etc.)

• Bachelors Degree in Mechanical or Biomedical Engineering
• A minimum of 2 years of experience in product design & development, preferably in medical devices. Orthopedic and/or complex system experience is a plus
• Knowledgeable in Microsoft Office software
• Extremely organized, dependable, analytical, and creative
• Excellent communication, reporting and documentation skills