Senior Development Engineer – Implants and Instruments

Location:
Ft. Lauderdale, FL

Job Description:
MAKO Surgical Corp. is looking for a Senior Development Engineer with a strong background in the medical device industry to develop orthopedic implants and instrumentation.

Responsibilities:

• Lead the design and development of new orthopedic implants and instrumentation and make improvements and modifications to current products
• Manage several engineering projects consisting of design, prototype development and testing through successful transition to manufacturing
• Generate project schedules, set milestones and communicate with project leaders and other departments as necessary
• Define and execute requirements definition, risk analysis, verification, validation, and design transfer processes for all products under direct responsibility
• Generate implant and instrumentation CAD models and detailed drawings using SolidWorks software
• Maintain device history files and gather information for regulatory submissions to ensure compliance with FDA Design Control regulations and to support 510(k) submissions
• Develop mechanical test protocols according to ASTM standards and coordinate the activities required to fabricate test parts and complete mechanical testing
• Interact with vendors to facilitate and improve manufacturability
• Interact with Marketing/Sales, Quality and Manufacturing Engineering (where appropriate) to resolve issues associated with product design
• Communicate with surgeons and sales consultants, understand clinical issues, define design parameters, and ensure that the correct product is provided to the customer
   

• Bachelor’s Degree in Mechanical or Biomedical Engineering
• 5-7+ years of experience in the field of medical device product design and development, preferably orthopedic experience
• A high level of SolidWorks CAD proficiency is required
• Knowledgeable in Micorsoft Office software, Microsoft Project, and SolidWorks
• Good communication, reporting and documentation skills