Senior Development Engineer, Implants

The Senior Development Engineer manages the design and development of implant and implant related instruments and projects from concept to product launch using his/her strong experience in human body biomechanics, medical device industry requirements, project management, and design controls.
Departmental Responsibilities:
  • Lead the design and development of new orthopedic implants and instrumentation and improvements and modifications to current products.
  • Oversee and participate in several simultaneous engineering projects consisting of design, prototype development and testing through successful transition to manufacturing and product launch.
  • Generate project schedules, set individual milestones, work independently on complex assignments from inception through timely, accurate completion and communicate with project leaders as necessary.
  • Define and execute specified requirements definition, risk analysis, verification, validation, and design transfer processes for all products under direct responsibility.
  • Maintain design history files to ensure compliance with FDA and international regulatory agencies design control regulations and to support the Regulatory team with necessary submissions and files.
  • Share technical knowledge; provide leadership, mentoring and professional guidance to junior engineers.
  • Provide technical support for marketing and sales such as design rationale, surgical technique, sales brochures, specification guides, computer animations, and prepare internal and external training presentations.
  • Generate implant and instrumentation CAD models and detailed drawings using SolidWorks software.
  • Develop mechanical test protocols according to external and internal standards and coordinate the activities required to fabricate test parts and complete mechanical testing at MAKO Surgical Corp. and/or outside testing laboratories.
  • Interact with MAKO manufacturing personnel and product suppliers to facilitate and improve manufacturability.
  • Interact with Product Management/Marketing/Sales and Quality (where appropriate) to obtain feedback on new product designs and necessary changes to existing designs.